Acenam 1250 mg effervescent tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Acenam 1250 mg effervescent tablets

Glucosamine

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Acenam 1250 mg effervescent tablets are and what they are used for
2. What you need to know before taking Acenam 1250 mg effervescent tablets
3. How to take Acenam 1250 mg effervescent tablets
4. Possible adverse effects
5. How to store Acenam 1250 mg effervescent tablets
6. Contents of the pack and other information

1. What Acenam 1250 mg effervescent tablets is and what it is used for

Glucosamine belongs to a group of medicines called anti-inflammatory, other anti-inflammatory and non-steroidal antirheumatic agents.

Each tablet of Acenam 1250 mg effervescent tablets contains 1500 mg of glucosamine hydrochloride, equivalent to 1250 mg of glucosamine.

Acenam is indicated for the relief of symptoms caused by mild to moderate osteoarthritis of the knee.

2. What you need to know before taking Acenam 1250 mg effervescent tablets

Do not take Acenam:

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Acenam.

• If you have impaired glucose tolerance (sugar intolerance). More frequent monitoring of blood sugar levels may be required when starting treatment with glucosamine.
• If you have any kidney or liver problems, as studies have not been conducted under these conditions and therefore no dosage recommendations can be given.
• If you have any risk factors for heart or arterial diseases, as increased cholesterol levels have been observed in some patients treated with glucosamine.
• If you have asthma. When starting treatment with glucosamine, you should be aware that symptoms may worsen.
• You should consult your doctor to rule out other joint diseases for which alternative treatments may be considered.
• Inform your doctor if you have diabetes mellitus.

Use of Acenam with other medicines

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

Certain medicines may interact with Acenam. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

Caution is recommended when administering Acenam in combination with other medicines, especially:

• Certain types of anticoagulant medicines used to prevent blood clotting (e.g., warfarin, dicoumarol, phenprocoumon, acenocoumarol, and phenindione). The effect of these medicines may be enhanced when used together with glucosamine. Therefore, patients receiving these combinations should be monitored more closely when starting or stopping glucosamine treatment.
• Antibiotics such as tetracyclines (medicines used to treat infections).

Consult your doctor.

Taking Acenam with food, drinks, and alcohol

You may take the tablets with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Acenam should not be used during pregnancy.

The use of glucosamine is not recommended during breastfeeding.

Driving and use of machines

No studies have been conducted on the effects of Acenam on the ability to drive or operate machinery.

However, if you experience dizziness or drowsiness due to the tablets, you should not drive or operate machinery.

Acenam contains sorbitol (E-420) and sodium

This medicine contains 295 mg of sorbitol per tablet.

This medicine contains 318.2 mg of sodium (the main component of table/cooking salt) per tablet. This corresponds to 16% of the maximum daily recommended sodium intake for an adult.

3. How to take Acenam 1250 mg effervescent tablets

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The initial dose is 1250 mg of glucosamine (1 effervescent tablet) as a single daily dose for symptom relief.

Symptom relief is normally observed after four weeks of starting treatment. Glucosamine is not indicated for the treatment of acute painful symptoms. Once symptom relief has been achieved, the dose may be reduced to 625 mg per day. If no improvement is seen after 2–3 months of treatment, continuation of glucosamine therapy should be reconsidered.

Acenam 1250 mg effervescent tablets are administered orally.

The tablets must first be dissolved in half a glass of water. The resulting solution may be taken with or without food.

If you take more Acenam 1250 mg effervescent tablets than you should

Contact your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service at 91 562 0420, indicating the name of the medicine and the amount ingested.

Signs and symptoms of overdose with glucosamine include headache, dizziness, confusion, joint pain, nausea, vomiting, diarrhoea, or constipation.

If you forget to take Acenam 1250 mg effervescent tablets

Do not take a double dose to make up for the missed doses.

Take your dose as soon as possible. If it is almost time for your next dose, wait until then to take your tablet.

Take the next dose according to your usual schedule.

If you stop taking Acenam 1250 mg effervescent tablets

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

Symptoms may reappear.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The most commonly observed are:

You must stop treatment with glucosamine and immediately contact your doctor if you experience symptoms of angioedema such as:

• Swelling of the face, tongue, or throat.
• Difficulty swallowing.
• Hives and difficulty breathing.

The most frequently observed are:

Common (affects 1 to 10 in every 100 people)

• Headache.
• Fatigue.
• Nausea.
• Abdominal pain.
• Indigestion.
• Diarrhea.
• Constipation.

Uncommon (affects 1 to 10 in every 1,000 people)

• Rash.
• Itching.
• Redness.
• Vomiting.

Frequency not known (cannot be estimated from available data)

• Dizziness.
• Worsening of asthma symptoms.
• Swelling in ankles, legs, and feet.
• Hives.
• Increased cholesterol levels and worsening of blood sugar (glucose) levels in people with diabetes mellitus.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Acenam 1250 mg effervescent tablets

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

Do not use ACENAM after the expiry date which is stated on the tube or carton after the abbreviation CAD. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Keep in the original packaging to protect from moisture.

Keep the container tightly closed.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Acenam 1250 mg effervescent tablets

• The active substance in this medicine is glucosamine. Each tablet contains 1,500 mg of glucosamine hydrochloride, equivalent to 1,250 mg of glucosamine.
• The other components (excipients) are: Anhydrous citric acid, sodium bicarbonate, anhydrous sodium carbonate, sorbitol (E-420), lemon flavour, acesulfame K, leucine.

Appearance of the product and contents of the pack

Acenam 1250 mg effervescent tablets are presented as white effervescent tablets. Each pack contains 30 tablets in 2 polypropylene tubes with polyethylene caps equipped with a desiccant agent (silica gel), each containing 15 effervescent tablets; 20 tablets in 1 tube containing 20 effervescent tablets; and packs of 40 tablets in two tubes of 20 effervescent tablets each.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Especialidades Farmacéuticas Centrum, S.A.

C/ Sagitario, 14

03006 Alicante, Spain

Manufacturer

E Pharma Trento S.p.A.

Via Provina, 2, I 38040 Ravina (Trento), Italy

Date of the most recent revision of this leaflet: May 2018.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).