400 mg film-coated tablets
glucosamine
What Revalenk is and what it is used for
Revalenk belongs to the group of non-steroidal anti-inflammatory and anti-rheumatic drugs.
Revalenk is used to relieve the symptoms of mild to moderate osteoarthritis of the knee (joint wear and tear).
Glucosamine contained in Revalenk 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 using Revalenk
Do not take Revalenk if you:
- is allergic to glucosamine or any of the other ingredients of this medicine (listed in section 6).
- is allergic (hypersensitive) to shellfish, as glucosamine is extracted from shellfish.
Warnings and cautions
Revalenk should not be used to treat acute pain symptoms.
Talk to your doctor, pharmacist, or nurse before taking Revalenk if you have:
- impaired glucose tolerance. Closer monitoring of your blood sugar level may be necessary at the beginning of treatment with Revalenk.
- a known risk factor for cardiovascular disease, as an abnormally high level of cholesterol in the blood, has been observed in a few patients treated with glucosamine
- asthma. When starting treatment with Revalenk, you should be aware that your symptoms may get worse.
Children and young people
Revalenk should not be used by children and adolescents under 18 years of age.
Other medicines and Revalenk
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Caution should be exercised if Revalenk needs to be combined with other medicines, in particular:
- certain types of medicines are used to prevent blood clots (eg warfarin, dicumarol, phenprocoumon, acenocoumarol, and fluindione). The effect of these drugs can be enhanced when used in conjunction with glucosamine. Patients treated with blood-thinning drugs will therefore be monitored extra closely when glucosamine therapy is started or stopped.
- tetracycline ( antibacterial drugs used to treat infections ).
Please contact your doctor for medical advice.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Revalenk should not be used during pregnancy.
Breast-feeding
The use of Revalenk during breastfeeding is not recommended.
Driving and using machines
No studies on the ability to drive and use machines have been performed. If you feel dizzy or tired
of the tablets, you should not drive or use machines.
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.
Revalenk contains potassium
This medicine contains 2.2 mmol (87 mg) potassium per tablet. This should be considered by patients with impaired renal function or patients on a low-potassium diet.
How to take Revalenk
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dosage
The recommended starting dose is 1 tablet 3 times daily (1200 mg glucosamine ), taken by mouth. Alternatively, the entire dose can be taken at a single time during the day.
Relief of symptoms (especially pain relief) may occur only after several weeks of treatment and in some cases after even longer. If no symptom relief has been obtained after 2-3 months, you should consult a physician and treatment should be evaluated.
For people with renal and/or hepatic impairment, no dose recommendations can be made, as no studies have been performed.
The tablets should be taken orally ( oral use).
The tablets should be swallowed together with water or other suitable liquid.
The tablet can be divided into two equal doses.
If you take more Revalenk than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center (tel. 112) for risk assessment and advice. Signs and symptoms of glucosamine overdose may include headache, dizziness, confusion, joint pain, nausea, vomiting, diarrhea, or constipation. Discontinue treatment if there are signs of overdose.
If you forget to take Revalenk
Do not take a double dose to make up for a forgotten dose. If it is almost time for your next dose, skip the missed dose and continue taking Revalenk as planned.
If you stop taking Revalenk
Tell your doctor, that a change in the treatment of your symptoms may be required.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Revalenk and call the emergency services immediately or see a hospital if you experience any of the following symptoms ( angioedema ):
- swelling of the face, tongue, or throat.
- difficulty swallowing.
- hives and difficulty breathing.
Other side effects that have been reported:
Common (may affect up to 1 in 10 people):
- headache, fatigue, nausea, abdominal pain, upper gastrointestinal symptoms, diarrhea, and constipation.
Uncommon (may affect up to 1 in 100 people):
- skin rash, itching, and redness.
Has been reported (occurs in an unknown number of users):
- hives , swelling of i.a. ankles, legs, and feet, dizziness, vomiting, impaired control of blood glucose in patients with diabetes, elevated liver enzyme levels, and jaundice.
How to store Revalenk
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. 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.
Contents of the pack and other information
Content declaration
- The active substance is glucosamine sulfate-potassium chloride equivalent to 400 mg glucosamine.
- Other ingredients are Tablet core: Anhydrous colloidal silica, microcrystalline cellulose, magnesium stearate, and purified water.Film coating: Hypromellos, macrogol 6000.
What the medicine looks like and the contents of the pack
Revalenk is white to off-white, oblong film-coated tablets with a score line, of approximately 19x8x7 mm.
Pack sizes: 90 or 180 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Mezina A / S
Energizer 4
6700 Esbjerg
Denmark
Manufacturer
Vimeo A / S
Lodshusvej 11
4230 Skælskør
Denmark
This medicine is authorized in the European Economic Area under the names:
Denmark: Glucosamine BBS