250 mg, 500 mg tablet 
naproxen

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

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

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– 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.

In this leaflet: 
1. What Alpoxen is and what it is used for 
2. What you need to know before you take Alpoxen 
3. How to take Alpoxen 
4. Possible side effects 
5. How to store Alpoxen 
6. Contents of the packaging and other information 

1. What Alpoxen is and what it is used for

Alpoxen is anti-inflammatory, analgesic, and antipyretic. Alpoxen belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory / anti-rheumatic medicines).

Alpoxen is used for rheumatoid arthritis, degenerative joint changes, spinal stiffness (Bechterew’s disease), acute migraine attacks, acute mild to moderate intensity pain, and menstrual cramps.

Naproxen contained in Alpoxen 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.

2. What you need to know before you take Alpoxen

Do not take Alpoxen

  • if you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6.)
  • if you have previously had allergic reactions such as asthma, runny nose, or rash when you have taken painkillers containing acetylsalicylic acid or other medicines for pain/inflammation within the group NSAID
  • if you have an increased tendency to bleed
  • if you have or have had recurrent stomach ulcers or duodenal ulcers
  • if you have had stomach ulcers or duodenal ulcers during treatment with naproxen or similar preparations
  • if you have severe liver disease
  • if you have severe heart failure
  • if you have severe kidney disease
  • during the last three months of pregnancy

Warnings and cautions

The lowest possible dose and the shortest possible treatment time should always be sought to reduce the risk of side effects. In general, higher doses than recommended can lead to risks. This also means that the combination of several NSAIDs at the same dose should be avoided.

If you have or have had any of the following conditions, you should consult a doctor before starting treatment with Alpoxen:

  • gastric ulcer or duodenal ulcer
  • inflammatory bowel disease ( ulcerative colitis, Crohn’s disease )
  • the skin disease SLE (connective tissue disease)
  • diseases with an increased tendency to bleed
  • impaired cardiac, hepatic or renal function
  • high blood pressure
  • asthma or allergies are

Elderly people should be aware of the increased risk of side effects that occur with older age.

Bleeding, ulcers, or rupture of the gastrointestinal tract, which can be fatal, have been reported with all NSAIDs and have occurred regardless of the duration of treatment, with or without warning symptoms or previous severe gastrointestinal side effects. Stop taking Alpoxen and contact a doctor immediately if you experience severe abdominal pain, or discover blood in your vomit or your stools.

Especially at the beginning of treatment, patients who have previously had problems with the gastrointestinal tract, especially elderly patients, should contact a doctor in case of symptoms from the abdomen.

Some patients with a high risk of side effects may be prescribed another medicine while taking Alpoxen to reduce the risk of gastrointestinal side effects.

Severe skin reactions when using NSAIDs have been reported in very rare cases. The risk of this reaction is higher at the beginning of treatment, most of the cases occur during the first month of treatment. Stop taking Alpoxen and consult a doctor if you get a rash or damage to the mucous membranes. See also section 4.

Medicines such as Alpoxen may have a small increased risk of heart attack or stroke. Such an increase in risk is more likely with the use of high doses and with long-term treatment. Do not exceed the recommended dose or treatment time (see section 3).

Consult your doctor or pharmacist about your treatment if you have heart problems, if you have had a stroke before, or if you think you are at risk for these conditions (eg if you have high blood pressure, diabetes, high cholesterol, or if you smoke).

After long-term use (more than 3 months) of Alpoxen every other day or more, headaches may develop or worsen. This headache should not be treated with a higher dose, but treatment with Alpoxen should then be stopped in consultation with a doctor.

The results of some urine tests may be affected if you take Alpoxen. Tell your doctor that you are taking Alpoxen if you are going to take a urine sample.

This medicine should not be used for chickenpox (see section 4).

Children

Children under 5 years of age should not be treated with Alpoxen.

Other medicines and Alpoxen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Never use several different painkillers at the same time without consulting a doctor or pharmacist.

Alpoxen can affect or be affected by certain other medicines, such as:

  • certain anticoagulants (eg warfarin, acetylsalicylic acid, ticlopidine)
  • certain anti-tumor drugs and disorders of the immune system (eg methotrexate)
  • certain antihypertensive agents (eg ACE inhibitors, angiotensin II inhibitors)
  • diuretic drugs
  • certain antidepressants ( SSRIs )
  • certain medicines for inflammation ( corticosteroids )
  • drugs containing lithium (for manic depression)
  • medicines containing tacrolimus, ciclosporin, probenecid, clopidogrel, or cholestyramine.
  • medicines for acid stomach (antacids).

Concomitant use of other NSAIDs should be avoided as the risk of side effects increases.

The alpoxen with food

The effect of Alpoxen can be delayed if taken with food at the same time.

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.

Pregnancy

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

Breast-feeding

Alpoxen passes into breast milk but is unlikely to affect breastfed infants. However, consult a physician if you use Alpoxen more than temporarily during breastfeeding.

Fertility

The use of Alpoxen may, as with any medicinal product that inhibits cyclooxygenase/prostaglandin synthesis, make it difficult to conceive. Tell your doctor if you are planning to have a baby or if you have problems getting pregnant.

Driving and using machines

Alpoxen can impair the reactivity of some people, which should be borne in mind at times when sharper attention is required, such as driving and precision work.

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.

Alpoxen contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Alpoxen

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

In rheumatic diseases and mild to moderate acute pain: the recommended dose for adults is 250-500 mg morning and evening, no more than 1,000 mg/day. In case of pronounced night and morning symptoms, a dose of 500 mg can be taken with the advantage in the evening.

Some patients may benefit from taking 750-1,000 mg once daily. When dosing with 1000 mg as a single dose, intake in the evening is recommended.

For menstrual pain: the recommended dose for adults is 250-500 mg if needed, but not more than 1,250 mg/day. Treatment is started at the first sign of menstrual bleeding.

In acute migraine attacks: the recommended dose for adults is 750 mg at the first sensation, then 250 mg if necessary, but not more than 1,250 mg/day.

Use for children and adolescents

Children over 5 years of age: the recommended dose is 125 mg (1/2 tablet of 250 mg) morning and evening. Children weighing more than 50 kg should use the same dose as adults.

Alpoxen is not recommended for children with acute pain.

The tablet can be divided into two equal doses.

If you forget to take Alpoxen

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.

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.

An adverse reaction is from the gastrointestinal tract such as digestive disorders, abdominal pain and nausea are the most common side effects are.

Ulcers, rupture, and/or bleeding in the gastrointestinal tract (sometimes fatal, especially in the elderly) may occur during treatment with Alpoxen.

Stop taking Alpoxen and contact a doctor immediately if you experience any of the following rare side effects (may affect up to 1 in 1,000 people):

  • A severe allergic reaction that causes difficulty breathing or dizziness
  • Swelling of the face, tongue, or throat; difficulty swallowing; hives and difficulty breathing ( angioedema ).
  • Serious skin reactions such as:
    • an extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes, as well as other mucous membranes such as genitals
    • severe widespread skin damage (skin peeling of the epidermis and superficial mucous membranes)
    • severe skin rash
  • Alex can in rare cases affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/throat/mouth or difficulty urinating, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis). It is important that you then information about your medication.

Other side effects include:

Common (may affect up to 1 to 10 users):

  • Drowsiness, dizziness, headache
  • Visual disturbances
  • Tinnitus
  • Palpitation
  • Acid reflux, heartburn, abdominal pain, nausea, vomiting, diarrhea, constipation, inflammation of the mouth, flatulence
  • Rash or superficial skin ulcers
  • Swelling in the body due to fluid retention ( edema ), thirst, sweating

Uncommon (may affect up to 1 to 100 users):

  • Difficulty sleeping, difficulty concentrating
  • Hearing loss
  • Asthma, shortness of breath
  • Intestinal bleeding, stomach ulcers, inflammation and sores in the mouth, bloody stools
  • Liver effects
  • Hives, photosensitivity that causes inflammation and blisters on the skin. Contact a doctor if you develop blisters on the skin.
  • Kidney impact
  • Hair loss, fever

Rare (may affect up to 1 in 1,000 people):

  • Meningitis
  • Impact on the blood picture
  • Elevated potassium levels in the blood
  • Mental disorders that can affect learning, memory, perception, and problem solving
  • Depression, nightmares, and mild anxiety
  • Seizures
  • Heart failure
  • Inflammation of the walls of blood vessels, high blood pressure
  • Pneumonia, fluid accumulation in the lungs
  • Inflammation of the colon, worsening of certain inflammatory bowel diseases ( Crohn’s disease, ulcerative colitis ), rupture of the stomach / intestinal wall, inflammation of the esophagus, inflammation of the pancreas, vomiting of blood, inflammation of the stomach
  • Hepatitis ( hepatitis, isolated cases have been fatal)
  • Muscle weakness, muscle pain
  • Bloody urine

Medicines such as Alpoxen may cause a slight increase in the risk of heart attack or stroke (see section 2 Warnings and precautions).

Drugs such as Alpoxen may affect the results of certain liver tests.

In rare cases, severe skin infections are associated with chickenpox.

Alpoxen may increase your risk of bleeding.

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 Alpoxen

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

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. 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 substance is naproxen. Each tablet contains 250 mg and 500 mg naproxen, respectively.
  • The other ingredients are lactose monohydrate 15 mg and 30 mg respectively, carmellose sodium, hypromellose, magnesium stearate, silica ( colloidal, anhydrous).

What the medicine looks like and the contents of the pack

Tablets 250 mg 
White, capsule-shaped tablets with a scoreline, marked “AL” on one side and marked “N” and “250” on the other side. 12 x 7 mm.

Printing packaging: 10, 20, 25, 28, 50×1 (single dose), 98 and 100 pcs. 
Plastic jar: 25, 30, 100, and 250 pcs (rheumatism packaging).

Tablets 500 mg 
White, capsule-shaped tablets with a scoreline, marked “AL” on one side and marked “N” and “500” on the other side. 18 x 8 mm.

Printing packaging: 10, 25, 28, 98, 98×1 (single dose) and 100 pcs.

Plastic jar: 25, 30, 100, and 250 pcs (rheumatism packaging).

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group hf

Reykjavikurvegur 76-78

IS-220 Hafnarfjordur

Iceland

Manufacturer

Allphamed PHARBIL Arzneimittel GmBH

Hildebrandstr. 12

37081 Göttingen

Germany

Muhammad Nadeem

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