vivimed

VIVIMED with caffeine for headache tablets

Important notes (mandatory information)

vivimed with caffeine for headaches, tablets.

Indications

for mild to moderate pain.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

vivimed with caffeine for headaches, tablets
Active ingredients: 1 tablet contains 333 mg paracetamol and 50 mg caffeine

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 3 days, contact your doctor.

What this package leaflet contains

1. WHAT IS VIVIMED WITH CAFFEINE FOR HEADACHES AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING VIVIMED WITH CAFFEINE FOR HEADACHES?
3. HOW TO TAKE VIVIMED WITH CAFFEINE FOR HEADACHES?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE VIVIMED WITH CAFFEINE FOR HEADACHES?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS VIVIMED WITH CAFFEINE FOR HEADACHES AND WHAT IS IT USED FOR?

vivimed with caffeine for headaches is a combination of paracetamol, a pain-relieving, fever-reducing medicine (analgesic and antipyretic) and caffeine.

Indications

For mild to moderate pain.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING VIVIMED WITH CAFFEINE FOR HEADACHES?

vivimed with caffeine for headaches must not be taken:

• if you are hypersensitive (allergic) to paracetamol, caffeine or any of the other ingredients of vivimed with caffeine for headaches.
• if you suffer from severe impairment of liver function.
• by children under 12 years of age.

Warnings and precautions

Only take vivimed with caffeine for headaches after consulting your doctor:

• if you are chronically alcoholic.
• if you suffer from impaired liver function (hepatitis, Gilbert syndrome).
• in case of damaged kidneys.
• in case of hyperthyroidism.
• in case of cardiac arrhythmias.
• in case of anxiety disorders.

If your symptoms worsen or do not improve after 3 days, or if you have a high fever, you must consult a doctor. To prevent the risk of overdose, it should be ensured that other medicines taken at the same time do not contain paracetamol. Prolonged, high-dose, non-prescription use of painkillers (analgesics) can lead to headaches that should not be treated with increased doses of the medicine. In general, the habitual use of painkillers, especially when several pain-relieving active ingredients are combined, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy). If abruptly discontinued after prolonged, high-dose, non-prescription use of painkillers, headaches, fatigue, muscle pain, nervousness and vegetative symptoms may occur. The withdrawal symptoms subside within a few days. Until then, painkillers should not be taken again and should not be taken again without medical advice. Do not use vivimed with caffeine for headaches for a long period of time or in higher doses without medical or dental advice.

When taking vivimed with caffeine for headaches together with other medicines

Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.

Paracetamol

Interactions are possible with:

• Medicines for gout such as probenecid: When probenecid is taken at the same time, the dose of vivimed with caffeine for headaches should be reduced, as the breakdown of vivimed with caffeine for headaches may be slowed down.
• Sleeping pills such as phenobarbital, medicines for epilepsy such as phenytoin, carbamazepine, medicines for tuberculosis (rifampicin) and other medicines that may damage the liver. Under certain circumstances, liver damage may occur if taken at the same time as vivimed with caffeine for headaches.
• Medicines for nausea (metoclopramide and domperidone) can accelerate the absorption and onset of action of vivimed with caffeine for headaches.
• Medicines to lower elevated blood lipid levels (cholestyramine) can reduce the absorption and thus the effectiveness of vivimed with caffeine for headaches.
• Medicines for HIV infections (zidovudine). The tendency to reduce white blood cells (neutropenia) is increased. vivimed with caffeine for headaches should therefore only be taken at the same time as zidovudine on medical advice.
• Medicines that slow down gastric emptying can lead to a delayed onset of action.

Effects of taking vivimed with caffeine for headaches on laboratory tests

Uric acid determination and blood sugar determination can be affected.

Caffeine:

• reduces the sleep-inducing effect of substances such as barbiturates (certain sleeping pills), antihistamines (certain medicines for allergies), etc.
• increases the heart rate-increasing effect of substances such as sympathomimetics (certain circulatory stimulants), thyroxine (certain thyroid medicines), etc.
• can increase the pain-relieving effect of paracetamol and some non-steroidal anti-inflammatory drugs (certain painkillers).
• reduces the excretion of theophylline (a certain medicine for the treatment of lung diseases).
• increases the dependence potential of substances of the ephedrine type.
• Oral contraceptives (contraceptives), cimetidine (a certain medicine for the treatment of stomach ulcers) and disulfiram (a certain alcohol withdrawal medicine) reduce the breakdown of caffeine in the liver, while barbiturates (certain sleeping pills) and smoking accelerate it.
• Quinolone carboxylic acid type gyrase inhibitors (certain medicines for the treatment of infections) can delay the elimination of caffeine and its breakdown product paraxanthine.

When taking vivimed with caffeine for headaches together with food and drink

vivimed with caffeine for headaches must not be taken together with alcohol.

Pregnancy and

breastfeeding

Ask your doctor or pharmacist for advice before taking/using any medicine.

Pregnancy

If necessary, vivimed with caffeine for headaches can be used during pregnancy. You should use the lowest possible dose that relieves your pain and/or fever, and you should use the medicine for the shortest possible time. Contact your doctor/midwife if the pain and/or fever is not relieved or if you need to take the medicine more often.

Breastfeeding

Paracetamol and caffeine, the active ingredients of vivimed with caffeine for headaches, pass into breast milk. Since no adverse effects on the infant have been reported to date, it is usually not necessary to interrupt breastfeeding. The infant's condition and behavior may be affected by caffeine taken in with breast milk. When used for a short period of time at the recommended dose, it is usually not necessary to interrupt breastfeeding. In case of prolonged use or higher doses, you should stop breastfeeding.

Driving and using machines

vivimed with caffeine for headaches has no influence on the ability to drive and use machines. Nevertheless, caution is always advised after taking a painkiller.

3. HOW TO TAKE VIVIMED WITH CAFFEINE FOR HEADACHES?

Always take vivimed with caffeine for headaches exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. The dosage depends on the information in the following table. The respective dosing interval depends on the symptoms and the maximum daily total dose. It should not be less than 6 hours. If symptoms persist for more than 3 days, a doctor should be consulted.

Body weight, age	Single dose in number of tablets	maximum daily dose in number of tablets
From 43 kg, children and adolescents from 12 years of age and adults	1 – 2 tablets (corresponding to 333 – 666 mg paracetamol and 50 –100 mg caffeine)	8 tablets (corresponding to 2664 mg paracetamol and 400 mg caffeine)

In patients with liver or kidney dysfunction and Gilbert syndrome, the dose must be reduced or the time interval extended.

Method of administration

Take the tablets unchewed with plenty of liquid. Taking the tablets after meals can lead to a delayed onset of action.

Duration of use

Do not take vivimed with caffeine for headaches for more than 3 days without medical or dental advice.

Special patient groups:

• Liver dysfunction and mild renal impairment: In patients with liver or kidney dysfunction and Gilbert syndrome, the dose must be reduced or the dosing interval extended.
• Severe renal insufficiency: In severe renal insufficiency (creatinine clearance < 10 ml/min), a dosing interval of at least 8 hours must be observed.
• Elderly patients: No special dose adjustment is required.
• Children under 12 years of age: There is insufficient knowledge for the use of vivimed with caffeine for headaches in children under 12 years of age.

If you have taken more vivimed with caffeine for headaches than you should

As a rule, side effects of a paracetamol overdose only occur if a maximum daily total dose of 60 mg/kg body weight for children and 4000 mg for adults and adolescents over 12 years of age is exceeded. Symptoms such as nausea, vomiting, loss of appetite, pallor and abdominal pain may occur within 24 hours. In addition, severe liver damage may occur. Please inform your doctor if you have taken a larger amount of paracetamol. In case of an overdose of caffeine, central nervous symptoms (e.g. restlessness, agitation, tremor) and cardiovascular reactions (e.g. rapid heartbeat, pain in the heart region) can be caused.

If you forget to take vivimed with caffeine for headaches

Do not take a double dose if you have forgotten to take the previous dose. Continue taking the medicine as described in the dosage instructions.

If you stop taking vivimed with caffeine for headaches

When used as directed, no special precautions need to be taken after discontinuing vivimed with caffeine for headaches.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, vivimed with caffeine for headaches can have side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Possible side effects

Liver and biliary disorders

Rarely, a slight increase in certain liver enzymes (serum transaminases) has been reported.

Immune system disorders

Very rarely, allergic reactions in the form of a simple skin rash or hives to an anaphylactic shock can occur. In the event of an anaphylactic shock, call the nearest doctor for help. Also very rarely, narrowing of the airways (analgesic asthma) has been triggered in sensitive individuals.

Blood and lymphatic system disorders

Very rarely, changes in the blood count have been reported, such as a reduced number of platelets (thrombocytopenia) or a severe reduction in certain white blood cells (agranulocytosis).

Nervous system disorders

Frequency not known: Insomnia and restlessness.

Gastrointestinal disorders

Frequency not known: Stomach upset.

Cardiovascular disorders

Frequency not known: Tachycardia.

Skin and subcutaneous tissue disorders

Very rarely, cases of severe skin reactions have been reported.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE VIVIMED WITH CAFFEINE FOR HEADACHES?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton or blister. The expiry date refers to the last day of the month.

Storage conditions

Do not store above 25°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What vivimed with caffeine for headaches contains

Active ingredients: Paracetamol and caffeine. 1 tablet contains 333 mg paracetamol and 50 mg caffeine. Other ingredients: Microcrystalline cellulose; Carboxymethyl starch sodium (Type A) (Ph.Eur.); Povidone (K-28-30); Magnesium stearate (Ph.Eur.).

Packs of 10, 20 and 30 tablets are available.

Pharmaceutical entrepreneur

Dr. Gerhard Mann chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165 - 173
13581 Berlin
E-mail: kontakt@bausch.com

Manufacturer

ICN Polfa Rzeszow S.A.
2 Przemystowa Street
35-959 Rzeszow,
Poland

This package leaflet was last revised in May 2019.

Source: Information from the package leaflet
Status: 01/2021
Indications: for mild to moderate pain.