20 mg tenoxicam tablets 

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 pass it on 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, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Alganex is and what it is used for 
2. What you need to know before taking Alganex 
3. How to take Alganex 
4. Possible side effects 
5. How to store Alganex 
6. Contents of the pack and other ingredients information

1. What Alganex is and what it is used for

Alganex is used to treat chronic rheumatoid arthritis ( rheumatoid arthritis ), joint wear and tear ( osteoarthritis ), and Bechterew’s disease (spinal stiffness) as well as a short-term treatment of mild to moderate, acute inflammation that is not tied to the joints. Alganex is also used for pain associated with menstruation or surgery.

Alganex is an anti-inflammatory agent, with analgesic and antipyretic properties. Alganex inhibits a group of substances in the body called prostaglandins, which are formed during inflammation, among other things.

2. What you need to know before you take Alganex

Do not take Alganex

  • if you are allergic to the active substance 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 similar preparations.
  • 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 tenoxicam or similar preparations
  • if you have liver scarring ( cirrhosis )
  • if you have severe heart failure
  • if you have severe kidney disease
  • if you are pregnant in 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 the following diseases, you should consult a doctor before starting treatment with Alganex:

  • gastric ulcer or duodenal ulcer
  • inflammatory bowel diseases (such as ulcerative colitis, Crohn’s disease )
  • SLE (connective tissue disease)
  • high blood pressure
  • heart failure
  • kidney or liver disease

Elderly people should be aware of the increased risk of side effects that exist in old age.

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 abdominal symptoms.

Medicines such as Alganex 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.

Talk to your doctor or pharmacist about your treatment if you have heart problems, if you have had a stroke before, or if you think you have an increased risk of these conditions (for example, if you have high blood pressure, diabetes, high cholesterol or if you smoke).

Do not give Alganex to children as experience is lacking.

The use of tenoxicam, like all medicines that inhibit cyclooxygenase/prostaglandin synthesis, may make it difficult to get pregnant. Tell your doctor if you are planning to become pregnant or if you have problems getting pregnant.

For chickenpox, this medicine should not be used.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before starting treatment, as Alganex contains lactose.

Other medicines and Alganex

The treatment effect may be affected if Alganex is taken at the same time as certain other medicines. Therefore, tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Alganex may affect or be affected by certain medicines (containing the following substances):

  • blood clots (eg warfarin, ticlopidine, acetylsalicylic acid )
  • cancer (methotrexate)
  • disorders of the immune system (methotrexate)
  • depression (so-called SSRIs )
  • high blood pressure (eg so-called beta-blockers, diuretics, ACE inhibitors, angiotensin II inhibitors)
  • inflammation ( corticosteroids are)
  • manic depression (lithium)
  • pain (so-called NSAIDs, acetylsalicylic acid )
  • organ rejection after transplantation (cyclosporine, tacrolimus)
  • high blood fats (cholestyramine)

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

Do not take Alganex if you are pregnant during the last three months of pregnancy, as there is an increased risk of complications for both mother and baby. If you are in the first and second trimesters of pregnancy, consult your doctor before taking this medicine.

Breast-feeding

Small amounts of Alganex pass into breast milk. Alganex should therefore not be used during breast-feeding.

Fertility

Using Alganex may make it difficult for you to get pregnant. Tell your doctor if you are undergoing a fertility examination.

Driving and using machines

During treatment with Alganex, in some patients, the ability to react may be reduced. This should be taken into account 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 sharpened 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.

3. How to take Alganex

Always take this medicine exactly as your doctor or pharmacist has told you.

Ask your doctor or pharmacist if you are unsure.

Dose one is determined by the doctor, who adjusts it individually for you.

Never change the prescribed dose yourself without consulting your doctor.

The usual dose for adults is 1 tablet per day.

Swallow the tablets together with at least 1/2 glass of water. The tablets can be divided.

Elderly :

Your doctor will determine your dose, which is usually lower than that of other adults. While you are taking Alganex, your doctor will want to see you check that you are getting the dose that is right for you and to look for any side effects. This is especially important if you are older. Risks are more likely with high doses and long-term treatment. Do not exceed the recommended dose or treatment time.

If you have the impression that the effect of Alganex is too strong or too weak, talk to your doctor or pharmacist.

Symptoms of overdose may include nausea, vomiting, abdominal pain, diarrhea, headache, dizziness, and drowsiness.

If you forget to take Alganex

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

4. Possible side effects

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

Serious side effects are

Stop taking Alganex and contact a doctor immediately if you get any of the following symptoms:

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

  • Agranulocytosis: In rare cases, Alganex can affect the white blood cells so that the defense of the 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.
  • Allergic reactions manifested by difficulty breathing, asthma, dizziness, drop in blood pressure
  • Angioedema: swelling of the face, tongue, or throat; difficulty swallowing; hives and difficulty breathing.

Very rare (may affect up to 1 in 10,000 people):

  • Lyell’s syndrome ( toxic epidermal necrolysis ): Severe widespread skin damage (dermal detachment of the epidermis and superficial mucous membranes).
  • Stevens-Johnson syndrome: 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.

Other side effects are

Most common (may affect up to 1 in 10 people): Headache, dizziness, gastrointestinal effects (such as abdominal pain, acid regurgitation, and nausea).

Uncommon (may affect up to 1 in 100 people): Fatigue, dry mouth, decreased appetite, rash, itching, sleep disorders, diarrhea, stomach ulcers, gastrointestinal bleeding, vomiting, constipation, bloody stools, inflammation of the oral mucosa, inflammation of the gastric mucosa, fluid retention ( edema ), dizziness, palpitations, elevated liver enzymes.

Rare (may affect up to 1 in 1,000 people): heart failure, high blood pressure, vasculitis, visual disturbances, tinnitus, flatulence, vomiting, worsening of certain inflammatory bowel diseases ( colitis and Crohn’s disease ), liver effects, blood effects (including increased bleeding) difficulty throwing water, photosensitivity, erythema multiforme ( inflammation of the skin).

Very rare (may affect up to 1 in 10,000 people): Pancreatitis ( inflammation of the pancreas).

Has been reported (occurs in an unknown number of users): Visual disturbances, confusion, hallucinations (eg hearing or seeing things that do not exist), paresthesia(abnormal sensations such as ant crawling, tingling, or numbness especially in the hands and feet), drowsiness, female infertility.

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

Medicines such as Alganex may have a small increased risk of heart attack or stroke.

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 Alganex

Store at a maximum of 30 ° C and out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. 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 tenoxicam 20 mg per tablet.
  • The other ingredients are lactose monohydrate 90 mg, iron oxide (dye E 172), titanium dioxide (dye E 171), hypromellose, maize starch, magnesium stearate, and talc.

What the medicine looks like and the contents of the pack

Alganex tablets are 6×12 mm, yellow-beige, oblong with a notch, and embossed ’20’.

Plastic jar containing 100 tablets.

Blister pack containing 100 tablets.

Marketing Authorization Holder and Manufacturer

Meda AB

Box 906

170 09 Solna

Tel: 08 630 1900

Email: info@meda.se

Manufacturer:

Meda Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

Alternatively

Cenexi SAS

52, rue Marcel and Jacques Gaucher

94120 Fontenay-sous-Bois

France

Muhammad Nadeem

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