Apofri

Effervescent tablet 500 mg / 50 mg 
(White, round, flat tablet with a diameter of 22 mm.)

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

– Save this information, you may need to read it again.

– Contact the pharmacy staff if you need more information or advice.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

– You must talk to a doctor if you do not feel better or if you feel worse after 3 days with fever and migraine and within 5 days with pain.

In this leaflet: 
1. What Acetylsalicylic Acid / Caffeine Apofri is and what it is used for 
2. What you need to know before you use Acetylsalicylic acid / Caffeine Apofri 
3. How to use Acetylsalicylic acid / Caffeine Apofri 
4. Possible side effects 
5. How to store Acetylsalicylic acid / Caffeine Apofri 
6. Contents of the pack and other information 

What Acetylsalicylic Acid / Caffeine Apofri is and what it is used for

Acetylsalicylic acid / Caffeine Apofri contains two active substances, acetylsalicylic acid, and caffeine. Acetylsalicylic acid / Caffeine Apofri has analgesic, anti-inflammatory, and antipyretic properties. Acetylsalicylic acid relieves pain by counteracting the formation of special substances, prostaglandins. The antipyretic effect is due to the fact that acetylsalicylic acid increases the body’s heat release. Caffeine enhances the analgesic effect of acetylsalicylic acid. Caffeine also has an analgesic effect through its astringent effect on dilated blood vessels in the brain e.g. in migraine. Caffeine also has an invigorating effect.

You must talk to a doctor if you do not feel better or if you feel worse after 3 days with fever and migraine and within 5 days with pain.

This medicine is used for temporary mild to moderate pain conditions, e.g. headaches, including migraine headaches, toothaches, muscle, and joint pain, menstrual cramps, and fever in colds.

Acetylsalicylic acid and caffeine contained in Acetylsalicylic acid / Caffeine Apofri may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Acetylsalicylic acid / Caffeine Apofri

Do not use Acetylsalicylic acid / Caffeine Apofri

– if you are allergic to acetylsalicylic acid, caffeine, or any of the other ingredients of this medicine (listed in section 6).

– if you have had a hypersensitivity reaction such as asthma, difficulty breathing, hay fever, or hives when taking acetylsalicylic acid or certain other medicines for pain and inflammation within the group NSAIDs (non-steroidal anti-inflammatory drugs)

– if you are bleeding

– if you have reduced platelet count ( thrombocytopenia )

– if you have stomach ulcers

– if you have severe kidney disease or cirrhosis of the liver ( liver cirrhosis )

– if you have severe heart failure

– during the last three months of pregnancy (see “Pregnancy and breast-feeding”)

Warnings and cautions

Talk to your doctor before using Acetylsalicylic acid / Caffeine Apofri :

– if you know you are allergic (hypersensitive) to acetylsalicylic acid, ibuprofen, or any other anti-inflammatory drug.

– if you are taking medicines that thin the blood to prevent blood clots ( anticoagulants )

– if you are taking diuretics

– if you have mild to moderate heart failure

– if you have mild to the moderate liver or kidney function

– if you have high blood pressure

– if you have asthma

– if you have had stomach ulcers

Children and young people

Acetylsalicylic acid / Caffeine Apofri should not be given to children under 14 years of age.

Medicines containing acetylsalicylic acid should not be given to people under 18 years of age without a fever without consulting a doctor due to the risk of developing Reye’s syndrome, a rare but serious medical condition.

Other medicines and Acetylsalicylic acid / Caffeine Apofri

Acetylsalicylic acid / Caffeine Apofri can affect or be affected by:

• Anticoagulants (medicines for blood clots)

• Corticosteroids (medicines for inflammation such as cortisone or prednisolone ) and other NSAIDs (medicines for pain and inflammation such as ibuprofen )

• Metamizole (for pain and fever)

• Digoxin (medicine for arrhythmias in the heart)

Ciclosporin and tacrolimus (against the rejection of transplanted organs)

• Methotrexate (for cancer and rheumatism)

• Valproic acid (for epilepsy )

• Nicotinic acid (for high blood fats)

• Diuretics and medicines for high blood pressure

• Probenecid (for gout )

• Adenosine (for arrhythmias in the heart)

• Clozapine (for schizophrenia)

• Lithium (for manic depressive illness)

• Sulphonylureas (medicines for type II diabetes )

• Ciprofloxacin, Norfloxacin ( antibiotics for infections )

• Phenylpropanolamine (anti-allergy medicine )

• Fluvoxamine (antidepressant)

• Phenytoin and carbamazepine (medicines used to treat epilepsy ).

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Higher doses than those recommended can lead to serious risks. Do not use different types of painkillers at the same time without a doctor’s prescription.

Acetylsalicylic acid / Caffeine Apofri with food, drink, and alcohol

Acetylsalicylic acid / Caffeine Apofri in combination with alcohol may increase the risk of stomach ulcers.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Acetylsalicylic acid / Caffeine Apofri, like many anti-inflammatory drugs (so-called NSAIDs ), can make it difficult to conceive and is therefore not recommended for women trying to conceive. The effect is temporary, ie ceases when you stop using these types of drugs.

Pregnant women should not use Acetylsalicylic acid / Caffeine Apofri during the last three months of pregnancy. Intake of Acetylsalicylic Acid / Caffeine Apofri should be avoided by women who are planning to become pregnant or are pregnant. Treatment during any part of the pregnancy should be done only after a doctor’s prescription .

Acetylsalicylic acid / Caffeine Apofri passes into breast milk but is unlikely to affect the breast-feeding baby. However, consult a physician if more than temporary use of Acetylsalicylic acid / Caffeine Apofri during breast-feeding.

Driving and using machines

Acetylsalicylic acid / Caffeine Apofri may impair the ability of some people to react, for example, due to side effects such as dizziness and fatigue. This should be borne in mind at times when sharper attention is required, for example when driving a car.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Acetylsalicylic acid / Caffeine Apofri contains sodium

This medicine contains 276 mg of sodium (the main ingredient in table salt/table salt) per effervescent tablet. This corresponds to 14% of the maximum recommended daily intake of sodium for adults. Consult your doctor or pharmacist if you need 2 or more effervescent tablets daily for a long period of time, especially if you have been prescribed a low-salt (sodium-poor) diet.

How to use Acetylsalicylic acid / Caffeine Apofri

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Acetylsalicylic acid / Caffeine Apofri effervescent tablets are intended for temporary discomfort.

The recommended dose for adults and adolescents over 14 years: 1-2 effervescent tablets 1-3 times a day or according to a doctor’s prescription, a maximum of 6 tablets per day. More than 2 tablets at a time do not provide a better analgesic effect. Contact a doctor if symptoms worsen or do not improve within 3 days for fever and migraine and within 5 days for pain.

Warning: Do not give to people under 18 years of age with fever without consulting a doctor due to the risk of developing Reye’s syndrome, a rare but serious medical condition.

Dissolve the effervescent tablets in half a glass of water.

Because caffeine is invigorating, it may be inappropriate to take this medicine at night.

Use for children and adolescents

Acetylsalicylic acid / Caffeine Apofri should not be given to children under 14 years of age.

Symptoms of overdose can be: headache, dizziness, cramps, vomiting, tinnitus, palpitations ( tachycardia ), abdominal pain, irritation, anxiety, and shortness of breath are examples of symptoms of overdose.

If you forget to use Acetylsalicylic acid / Caffeine Apofri

Do not take a double dose to make up for a forgotten tablet.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (affects more than 1 user in 100):

• stomach upset, such as acid reflux, heartburn, and nausea

• increased tendency for bleeding

• palpitations, tremors, anxiety, insomnia.

Uncommon (affects less than 1 user in 100):

• fatigue, sweating, dizziness, and tinnitus

• hypersensitivity reactions such as hives, hay fever, or shortness of breath

• stomach ulcers and stomach bleeding.

Rare (affects less than 1 user in 1,000):

• reduction in platelet count ( thrombocytopenia )

Dissolution of the red blood cells ( hemolysis ) in those who have a hereditary deficiency of the metabolic enzyme glucose -6-phosphate dehydrogenase

• severe bleeding in the gastrointestinal tract

• severe skin reactions

• liver effects

• kidney effects.

Minor blood loss can in some cases lead to anemia.

Additional side effects are in children and adolescents

Acetylsalicylic acid may increase the risk of Reye’s syndrome in children and adolescents associated with viral diseases, especially chickenpox and influenza. Reye’s syndrome is very rare. The symptoms are signs of brain swelling and liver damage, sometimes with low blood sugar.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Acetylsalicylic acid / Caffeine Apofri

Keep this medicine out of the sight and reach of children.

Store in the original package. Close the tube tightly. Moisture sensitive.

Do not use this medicine after the expiry date which is stated on the carton and tube after EXP. date. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substances are acetylsalicylic acid 500 mg, caffeine 50 mg.

The other ingredients are anhydrous citric acid, povidone, sodium bicarbonate, anhydrous sodium carbonate, simethicone, sodium dihydrogen citrate, sodium citrate, mannitol, and docusate sodium.

What the medicine looks like and the contents of the pack

The effervescent tablets are white, round, flat and 22 mm in diameter.

The effervescent tablets are available in plastic tubes containing 10 or 25 effervescent tablets.

Pack sizes:

10, 15, 20, and 25 effervescent tablets in plastic tubes.

10 pcs (1 plastic tube x 10 effervescent tablets ), 15 pcs (1×15), 20 pcs (1×20, 2×10), 25 pcs (1×25), 30 pcs (3×10, 2×15), 40 pcs (4×10, 2×20), 45 pcs ( 3×15), 50 pcs (5×10, 2×25 pcs), 60 pcs (6×10, 4×15, 3×20) in outer carton.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Apofri AB

Box 120

182 12 Danderyd

Tel .: 08-544 960 30

Manufacturer

RosenPharma as

no. of descriptive 265

664 81 Veverské Knínice

Czech Republic

Muhammad Nadeem

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