dona

DONA 750 mg film-coated tablets

Important notes (mandatory information)

dona 750 mg film-coated tablets. Active ingredient: glucosamine hemisulphate. Areas of application: for the relief of symptoms of mild to moderate osteoarthritis of the knee joint.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

dona 750 mg film-coated tablets for use in adults
Active ingredient: glucosamine hemisulphate

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. This medicine is available without a prescription. Always take 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 2–3 months, contact your doctor.

What this package leaflet contains

1. WHAT ARE DONA 750 MG FILM-COATED TABLETS AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE TAKING DONA 750 MG FILM-COATED TABLETS?
3. HOW SHOULD YOU TAKE DONA 750 MG FILM-COATED TABLETS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD DONA 750 MG FILM-COATED TABLETS BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE DONA 750 MG FILM-COATED TABLETS AND WHAT ARE THEY USED FOR?

dona 750 mg film-coated tablets belong to a group of medicines called other non-steroidal anti-inflammatory (antiphlogistic) and antirheumatic medicines. dona 750 mg film-coated tablets are used for the relief of symptoms of mild to moderate osteoarthritis of the knee joint.

2. WHAT SHOULD YOU BE AWARE OF BEFORE TAKING DONA 750 MG FILM-COATED TABLETS?

dona 750 mg film-coated tablets must not be taken:

• if you are allergic to glucosamine or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to shellfish, as glucosamine is made from shellfish.

Warnings and precautions

Please talk to your doctor or pharmacist before taking dona 750 mg film-coated tablets.

Special care should be taken when taking dona 750 mg film-coated tablets:

• if you have impaired glucose tolerance. More frequent monitoring of blood sugar levels may be necessary at the start of treatment with glucosamine.
• if you have a known increased risk of cardiovascular disease, as increases in blood lipid levels have been observed in some patients treated with glucosamine.
• if you have asthma. You should be prepared for a possible increase in symptoms when you start taking glucosamine.
• if you have concomitant diseases. These may require different treatment.

Children and adolescents

Due to the lack of data on safety and efficacy, dona 750 mg film-coated tablets should not be used in children and adolescents under 18 years of age.

Elderly people

No specific studies have been conducted in elderly patients, but based on clinical experience, no dosage adjustment is necessary when treating otherwise healthy elderly people.

Impaired liver or kidney function

No studies have been conducted in patients with impaired liver or kidney function. Therefore, no dosage recommendations can be given for these patients.

Taking dona 750 mg film-coated tablets with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Caution is advised if dona 750 mg film-coated tablets are combined with other medicines, in particular with:

• certain types of medicines used to inhibit blood clotting (e.g. warfarin, dicumarol, phenprocoumon, acenocoumarol and fluindione). The effect of these medicines may be stronger when used with glucosamine. Patients treated with such combinations should therefore be monitored particularly carefully when starting or stopping glucosamine therapy.
• tetracycline antibiotics.

Taking dona 750 mg film-coated tablets with food and drink

The film-coated tablets can be taken with or without food.

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

dona 750 mg film-coated tablets should not be taken during pregnancy.

Breastfeeding

Taking glucosamine during breastfeeding is not recommended.

Driving and using machines

No studies on the effects on the ability to drive or use machines have been performed. If you experience dizziness or drowsiness, it is recommended that you refrain from driving or operating machinery.

dona 750 mg film-coated tablets contain sodium

This medicine contains 151.2 mg sodium (main component of cooking/table salt) per daily dose. This corresponds to 7.6% of the maximum daily recommended intake of sodium for an adult.

3. HOW SHOULD YOU TAKE DONA 750 MG FILM-COATED TABLETS?

Always take this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is

Take one dona 750 film-coated tablet twice a day.

Glucosamine is not indicated for the treatment of acute painful symptoms, as relief of symptoms (especially pain relief) only occurs a few weeks after the start of treatment, in some cases even later. If no relief of symptoms is observed after 2 - 3 months, the continuation of treatment with glucosamine should be reviewed. The film-coated tablets should be taken unchewed with plenty of water or a suitable liquid, preferably in the morning and evening with meals.

If you have taken more dona 750 mg film-coated tablets than you should

If you have taken more dona 750 mg film-coated tablets than you should, you must contact your doctor or a hospital.

If you forget to take dona 750 mg film-coated tablets

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

If you stop taking dona 750 mg film-coated tablets

Your symptoms may return.

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

The following side effects have been reported

Common (1 to 10 in 100 people treated):

• Headache, tiredness, drowsiness
• Nausea, abdominal pain, indigestion, flatulence, diarrhoea, constipation

Uncommon (1 to 10 in 1,000 people treated):

• Feeling hot
• Eczema, itching, skin redness, rash

Not known (frequency cannot be estimated from the available data):

• Allergic reaction
• Feeling dizzy
• Visual disturbances
• Asthma – as well as worsening asthma
• Vomiting
• Jaundice
• Angioedema, hives
• Oedema – as well as peripheral oedema
• Increased liver enzymes

Blood sugar control may be more difficult in patients with diabetes mellitus. The frequency is not known. Isolated, spontaneous cases of increased cholesterol levels have been reported, but a causal relationship has not been established.

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, Pharmacovigilance Department, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW SHOULD DONA 750 MG FILM-COATED TABLETS BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton/container. The expiry date refers to the last day of the month indicated. Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer use it. This helps to protect the environment. Further information can be found at www.bfarm.de/arzneimittelentsorgung.

Storage conditions

Do not store above 25°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What dona 750 mg film-coated tablets contain

The active ingredient is: glucosamine hemisulphate. One film-coated tablet contains: 942 mg glucosamine hemisulphate sodium chloride (1:1), corresponding to 750 mg glucosamine hemisulphate or 589 mg glucosamine. The other ingredients are: microcrystalline cellulose, povidone K 25, croscarmellose sodium, macrogol 6000, magnesium stearate (Ph. Eur.) [vegetable], talc, methacrylic acid-methyl methacrylate copolymer (1:1) (Ph. Eur.) ((MW: approx. 135000)), titanium dioxide, ammonium methacrylate copolymer (type A) ((x:y:z approx. 1:2:0.2; MW: approx. 150000)), triacetin.

What dona 750 mg film-coated tablets look like and contents of the pack

dona 750 mg film-coated tablets are available in packs of 20, 60, 84 and 180 film-coated tablets. The fill level of the cans is technically determined.

Pharmaceutical entrepreneur

MEDA Pharma GmbH & Co. KG
Benzstraße 1
61352 Bad Homburg

Manufacturer

GmbH
51101 Köln

This package leaflet was last revised in March 2021.

Source: Information from the package leaflet
Status: 11/2021
Active ingredient: glucosamine hemisulphate. Areas of application: for the relief of symptoms of mild to moderate osteoarthritis of the knee joint.