Grippostad C forte Granules for the preparation of a solution for oral use

Grippostad C forte is a medicine for simple colds with certain symptoms.

Application

1. What is Grippostad C forte and what is it used for?

Grippostad C forte is a medicine used to treat simple colds with certain symptoms. It contains paracetamol, ascorbic acid, caffeine and chlorphenamine hydrogen maleate as active ingredients.

Paracetamol relieves pain and reduces fever.
Chlorphenamine hydrogen maleate belongs to the group of antihistamines (medicines against allergies), supports the decongestion of the nasal mucosa and the reduction of mucus production and thus promotes unhindered nasal breathing.
Caffeine has a mildly stimulating effect and enhances the pain-relieving effect of paracetamol. It thus enables a reduction of the paracetamol dose, whereby the body is burdened with smaller amounts of painkillers.
Vitamin C (ascorbic acid) is vital for the human body and influences a multitude of metabolic processes. A deficiency of vitamin C impairs the reactions of the immune defence system.

Grippostad C forte is used
for the symptomatic treatment of common complaints such as headache and pain in the limbs, cold and chesty cough in the context of a simple cold. In the case of simultaneous fever or increased body temperature, Grippostad C forte granules have an antipyretic effect.

Due to the fixed combination of active ingredients in Grippostad C forte, no individual dose adjustment can be made in the case of complaints that predominantly affect one of the symptoms mentioned. In such situations, medicines in a different composition are preferable.

If you do not feel better or even worse after 3 days, contact your doctor.

.

How is it applied?

What is Grippostad C forte and what is it used for?

Grippostad C forte is a medicine for simple colds with certain symptoms. It contains paracetamol, ascorbic acid, caffeine and chlorphenamine hydrogen maleate as active ingredients.

Paracetamol relieves pain and reduces fever.
Chlorphenamine hydrogen maleate belongs to the group of antihistamines (medicines against allergies), supports the decongestion of the nasal mucosa and the reduction of mucus production and thus promotes unhindered nasal breathing. Caffeine has a mild stimulating effect and enhances the analgesic effect of paracetamol. It thus enables a reduction of the paracetamol dose, which means that the body is loaded with smaller amounts of painkillers.
Vitamin C (ascorbic acid) is vital for the human body and influences a multitude of metabolic processes. A deficiency of vitamin C impairs the reactions of the immune defence.

Grippostad C forte is used
for the symptomatic treatment of common complaints such as headache and pain in the limbs, runny nose and irritating cough as part of a simple cold. In the case of simultaneous fever or increased body temperature, Grippostad C forte granules have an antipyretic effect.

Due to the fixed combination of active ingredients in Grippostad C forte, no individual dosage adjustment can be made in the case of complaints that predominantly affect one of the symptoms mentioned. In such situations, medicines with a different composition are preferable.

If you do not feel better or even worse after 3 days, consult your doctor.

.

What should you pay attention to before taking it?

What should you be aware of before taking Grippostad C forte?

Grippostad C forte must not be taken

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• If you are allergic to paracetamol, ascorbic acid, caffeine, chlorphenamine hydrogen maleate, dexchlorphenamine or any of the other ingredients of this medicine listed in section 6
.
• If you suffer from a certain hereditary metabolic disease (glucose-6-phosphate dehydrogenase deficiency)
.
• if you suffer from severe renal insufficiency
.
• If you have severe liver insufficiency
.
• If you suffer from an increase in intraocular pressure (narrow-angle glaucoma)
.
• for prostate adenoma with residual urine formation
.
• If you have a tumour of the adrenal medulla
.
• When taking a medicine containing the active substance chloramphenicol at the same time (see section 2: "Taking Grippostad C forte with other medicines")
.
• In case of excessive or regular alcohol consumption
.
• If you suffer from cardiac arrhythmias
.
• if you have gastrointestinal ulcers
.
• If you suffer from kidney stones (oxalate stones)
.
• If you suffer from certain diseases in which too much iron is stored in the body ("thalassaemia", "haemochromatosis", "sideroblastic anaemia")
.
• of children under 12 years
• if you are pregnant
• If you are breastfeeding

Warnings and precautions.
Please talk to your pharmacist before taking Grippostad C forte.Grippostad C forte should only be used with special care or after consulting your doctor:

• if you have kidney dysfunction
.
• If you have an impairment of liver function, such as hepatitis or a congenital disease with jaundice (Gilbert's syndrome or Meulengracht's disease)
.
• If you have narrowing of the stomach outlet and/or narrowing of the urinary bladder outlet
.
• If you have hyperthyroidism (risk of caffeine side effects)
.
• for anxiety disorders (danger of reinforcement).

General information on painkillers:
Possible concomitant diseases
If fever persists, there are signs of a (second) infection, the symptoms persist for more than three days, the symptoms worsen or additional symptoms occur, the doctor must be consulted.
Without medical or dental advice, you should generally not take medicines containing paracetamol (such as Grippostad C forte) for longer than 3 days and not in increased amounts.

Painkiller headache
Prolonged and high-dose use outside the recommended dosage and duration of use of medicines containing painkillers (such as Grippostad C forte) may cause headaches that must not be treated by increased doses of the medicine.

Kidney damage
In general, the habitual use of painkillers, especially when combined with several analgesic agents, can lead to permanent kidney damage with the risk of kidney failure.

Stopping painkillers
If medicines containing painkillers (such as e.g. Grippostad C forte) are stopped abruptly after prolonged high-dose (not intended) use, headaches as well as muscle pain, nervousness and other complaints such as sweating, dizziness, trembling, palpitations may occur. Grippostad C forte), headaches as well as tiredness, muscle pain, nervousness and other complaints such as sweating, dizziness, trembling, palpitations may occur. These symptoms usually disappear within a few days after stopping the medicine. Otherwise, please contact your doctor immediately. Until then, do not take painkillers again and do not take them again without medical advice.

Warnings
Exceeding the recommended dose can, as with all medicines containing paracetamol (such as Grippostad C forte), lead to kidney damage and very serious liver damage. An antidote must then be administered as soon as possible (see section 3). In this case, immediate medical treatment is required.

To avoid the risk of overdose, it must be ensured that medicines taken at the same time do not contain paracetamol. Please ask your doctor or pharmacist whether the medicines you are taking at the same time are paracetamol-containing medicines and whether the dosage needs to be adjusted.

When high doses of Grippostad C forte are taken, the ascorbic acid (vitamin C) contained in the product can lead to "severe" symptoms in patients with so-called "erythrocytic glucose-6-phosphate dehydrogenase deficiency". "erythrocytic glucose-6-phosphate dehydrogenase deficiency" (a hereditary disorder of the metabolism of red blood cells), "severe haemolysis" (dissolution of red blood cells) may occur in individual cases. Therefore, the use of Grippostad C forte is not permitted in this particular hereditary metabolic disorder (glucose-6-phosphate dehydrogenase deficiency). And in general, do not exceed the recommended dosage.

If you are prone to kidney stone formation, there is a risk of kidney stones (calcium oxalate stones) forming if you take large amounts of Grippostad C forte due to the ascorbic acid (vitamin C) it contains. Patients with recurrent kidney stone formation are recommended not to exceed a daily intake of 100 to 200 mg vitamin C. Grippostad C forte contains 300 mg vitamin C per sachet.
Trafficability
Grippostad C forte can severely impair the ability to react, even when used in the recommended dose range (see " Driving ability and capability to operate machinery").

Taking Grippostad C forte with other medicinesInform your doctor or pharmacist if you are taking/using, have recently taken/used or do not intend to take/use any other medicines.

Interactions of the active ingredients contained in Grippostad C forte are possible with:

• Drugs that cause slowing of gastric emptying (e.g. propantheline). Such medicines can delay the absorption of paracetamol into the body and lead to a slower onset of action of Grippostad C forte.
• Drugs that cause acceleration of gastric emptying (e.g. metoclopramide). These medicines can accelerate the absorption of paracetamol into the body and lead to a faster onset of action of Grippostad C forte.
• Certain medicines for the treatment of HIV infection (zidovudine). The tendency to a reduction in white blood cells (neutropenia) is increased. Grippostad C forte should therefore only be used at the same time as zidovudine on medical advice.
• Certain medicines forgout (probenecid). If probenecid is taken at the same time, your doctor may reduce the dose of Grippostad C forte, as the breakdown of Grippostad C forte in the body may be slowed.
• Certain medicines for pain and fever (salicylamides). With simultaneous use of salicylamides, the degradation of Grippostad C forte may be prolonged.
• Drugs that activate certain metabolic enzymes in the liver that are involved in the breakdown of drugs in the body. These include, for example, certain sleep aids (barbiturates), medicines for the treatment ofepilepsy (phenytoin, carbamazepine) or medicines for the treatment oftuberculosis (rifampicin). The simultaneous use of these medicinal products may increase the liver-damaging effect of Grippostad C forte.
• Alcohol: The simultaneous consumption of alcohol also increases the liver-damaging effect of Grippostad C forte.
• Certain antibiotics = medicines against infections (chloramphenicol): the combination with Grippostad C forte increases the harmful effect due to slower excretion of the antibiotic (increased side-effects possible).
• Medicines toinhibit blood clotting ("anticoagulants"). Repeated use of Grippostad C forte for more than one week may increase the effect of anticoagulant medicines, due to the active substance paracetamol contained in them.
• Certain medicines to lower elevated blood fat levels (colestyramine). When used at the same time as colestyramine, the absorption and the effect of Grippostad C forte may be reduced.
• Medicines with sleep-inducing effects, such as e.g. Sleeping pills (barbiturates), medicines for the treatment ofallergies (antihistamines), or medicines for the treatment ofmental and psychological disorders (psychotropic drugs) or alcohol. When used at the same time, the sleep-promoting effect of these medicines may be increased by Grippostad C forte.
• Drugs with heart rate-increasing effects, such as sympathomimetics (blood pressure-increasing drugs) and thyroid hormones (thyroxine). The heart rate-increasing effect of these medicines may be increased when used at the same time as Grippostad C forte.
• Certain medicines for the treatment of bronchial asthma (theophylline). The excretion of theophylline from the body may be reduced when used at the same time as Grippostad C forte and the effect of theophylline may be increased.
• Ephedrine and related substances (e.g. in some cold remedies and medicines for hay fever). Simultaneous use with Grippostad C forte increases the risk of possible undesirable interactions and should therefore not be used at the same time.
• Drugs with a broad range of action, such as sleepand tranquillisers of the benzodiazepine type. When combined with Grippostad C forte, different and unpredictable interactions may occur. If you notice any interactions when taking such medicines at the same time, please inform your doctor immediately.
• certain antibiotics (gyrase inhibitors of the quinolone carboxylic acid type). These medicines may delay the excretion of Grippostad C forte from the body.
• Certain medicines for the treatment of migraine (ergotamine). Grippostad C forte can accelerate the absorption of ergotamine into the body.
• Iron and aluminium. Grippostad C forte can increase the absorption of iron and aluminium from the digestive tract. This is especially important in patients with impaired kidney function, when taking iron preparations and aluminium-containing gastroprotective agents(agents to neutralise gastric acid).
• Drugs forinhibition of blood clotting. Grippostad C forte also influences, through the vitamin C it contains, the effect of agents for inhibiting blood clotting, such as warfarin.
• Certain medicines againstgastrointestinal ulcers (nitazidine): leads to increased plasma levels of paracetamol.
• Certain medicines againstgastrointestinal complaints (cisapride): increases the absorption of paracetamol in the body.
• Lamotrigine: Simultaneous administration of paracetamol and lamotrigine (specific drug for the treatment of epilepsy) leads to reduced availability of lamotrigine.
• Ethinylestradiol: Due to the vitamin C it contains, Grippostad C forte can increase the blood levels of ethinylestradiol (a component of some oral contraceptives = "antibaby pills") and, in rare cases, lead to spotting.
• Certain painkillers(acetylsalicylic acid): reduce the absorption of vitamin C in the body.
• Certain medicines againsttoo much iron in the blood (deferoxamine). If deferoxamine is taken at the same time as Grippostad C forte, cardiac function may be impaired, which returns to normal after discontinuation of Grippostad C forte.
• A certain medicinal product for the treatment of mental and mental disorders (fluphenazine).
• Certain medicines for the treatment of stomach ulcers such as cimetidine, oral contraceptives (the "pill") and certain alcohol withdrawal medicines such as disulfiram: reduce the breakdown of Grippostad C forte.
• Certain sleep aids and sedatives such as barbiturates and smoking: accelerate the breakdown of Grippostad C forte.
• Vitamin B12: The vitamin C contained in Grippostad C forte can reduce the effect of vitamin B12, which is why these preparations should be used at different times.

Taking Grippostad C forte with food, drinks and alcohol
Grippostad C forte must not be taken together with alcohol, as alcohol can influence the effect and side effects (especially liver damage) of Grippostad C forte.

Pregnancy and breastfeeding.
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
If you are pregnant, you must not take Grippostad C forte.

breastfeeding
If you are breast-feeding, you must not take Grippostad C forte, as the ingredients of Grippostad C forte may pass into breast milk.

Driving ability and ability to operate machinery.
! Caution: This medicinal product may impair the ability to react and drive.

Even when used in the recommended dose range, this medicine may alter the ability to react to such an extent that the ability to actively participate in road traffic and/or to operate machinery is impaired. This is especially true in combination with alcohol.

Therefore, you should not drive a vehicle or operate machinery or perform other activities with potentially dangerous effects.

Grippostad C forte contains sodium.
This medicine contains 128 mg of sodium per sachet.
This corresponds to 6.4% of the maximum daily dietary sodium intake recommended for an adult.

How should the medicine be taken?

How to take Grippostad C forte?

Always take Grippostad C forte exactly as described in this leaflet or as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Adults and adolescents aged 12 years and over
Adults and adolescents aged 12 years and over take the contents of one sachet 3 times a day at least 6 hours apart.

Patients with impaired liver and/or kidney function
In patients with liver and/or kidney dysfunction and a congenital disease with jaundice ("Gilbert's syndrome" or "Meulengracht's disease"), the dose must be reduced or the dose interval extended. Please talk to your doctor about this.

You must not take Grippostad C forte if your liver and/or kidney function is severely restricted (see under 2. Grippostad C forte must not be taken).

Older patients (65 years and over)
No special dose adjustment is required on the basis of age. In case of underweight and/or organ dysfunction, please follow the corresponding instructions.

Type and duration of use
To be taken after dissolving.

Please add the contents of one sachet to a glass of water. The granules dissolve after about one minute without stirring. Then drink the contents of the glass completely.

The duration of use should be limited to the duration of the illness.
Grippostad C forte must not be taken for longer than 3 days without medical consultation. If the symptoms persist for longer than 3 days, a doctor must be consulted.

Please talk to your doctor or pharmacist if you have the impression that the effect of Grippostad C forte is too strong or too weak.

If you have taken a larger amount of Grippostad C forte than you should

.If you suspect you have taken an overdose of Grippostad C forte, tell a doctor immediately so that he or she can decide what to do. Depending on how long ago the drug was taken, the doctor will take the necessary measures. Show the doctor your tablet pack.

The following signs may indicate an overdose with Grippostad C forte, which consist of signs of poisoning with the individual substances (paracetamol, chlorphenamine hydrogen maleate, caffeine and ascorbic acid (vitamin C)):

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• Paracetamol: In case of overdose, nausea, vomiting, loss of appetite, pallor and abdominal pain may occur initially (on day 1). Despite improvement of the general condition on day 2, progressive damage to the liver may occur.
• Chlorphenamine hydrogen maleate: In case of overdose, redness of the face, disturbances of movement and coordination, agitation, sensory illusions, muscle tremors, convulsions, fixed and dilated pupils, dry mouth, constipation and very high fever may occur. This can lead to coma, respiratory paralysis and cardiovascular collapse. Furthermore, excitation or dulling of the central nervous system may occur, especially in children.
• Caffeine: In case of overdose, tremors, central nervous system disorders such as seizures and cardiovascular disorders may occur.
• Ascorbic acid (vitamin C): In high doses, temporary diarrhoea may occur, gastrointestinal disturbances such as nausea. Patients with a tendency to kidney stones are at risk of developing kidney stones.

The risks of overdosage increase in particular in elderly people, small children, people with liver disease, regular alcohol abuse, regular malnutrition or undernutrition and in the case of simultaneous use of medicines that lead to an increased effect of certain liver enzymes. The risks of overdose increase in particular in elderly people, small children, people with regular alcohol abuse, regular malnutrition or undernourishment and in the simultaneous intake of medicines that lead to an increased effect of certain liver enzymes. In In these cases, an overdose can lead to death.

More information for your doctor and other healthcare professionals. contains the relevant section at the end of the leaflet.

If you have forgotten to take Grippostad C forte.
Do not take twice the amount if you have forgotten to take it before, but continue as described in the dosage instructions.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What are the possible side effects?

How should Grippostad C forte be stored?

No special storage conditions are required for this medicinal product.

Keep this medicinal product out of the reach of children.

You must not use this medicinal product after the expiry date which is stated on the outer carton and the sachet after "EXP" and "EXP" respectively. The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

5. How should Grippostad C forte be stored?

No special storage conditions are required for this medicinal product.

Keep this medicinal product out of the reach of children.

You must not use this medicinal product after the expiry date which is stated on the outer carton and the sachet after, "Use by". The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it.

You are helping to protect the environment.

Special notes on the content

Contents of the pack and other information

What Grippostad C forte contains
The active ingredients are: Paracetamol, ascorbic acid (vitamin C), caffeine and chlorphenamine hydrogen maleate.
1 sachet of 2.02 g granules contains 400 mg paracetamol, 300 mg ascorbic acid, 50 mg caffeine, 5 mg chlorphenamine hydrogen maleate.

The other ingredients are: anhydrous citric acid (Ph.Eur.), sodium hydrogen carbonate, sodium cyclamate, saccharin sodium, povidone, riboflavin phosphate sodium (Ph.Eur.), talcum powder, lemon flavouring

What Grippostad C forte looks like and contents of the pack
Granules for oral use
White or almost white granules. Grippostad C forte is available in packs of 12 sachets.