Leaflet:information for the patient

Acenam 1250 mg effervescent tablets

Glucosamine

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

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor, pharmacist or nurse.

- This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Acenam 1250 mg effervescent tablets

4. Possible side effects

5. Storage of Acenam 1250 mg effervescent tablets

6. Contents of the pack and additional information

Glucosamine belongs to a group of medicines called nonsteroidal anti-inflammatory drugs and other anti-inflammatory and antirheumatic agents.

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

Acenam is indicated to relieve symptoms caused by mild to moderate knee arthritis

Do not take Acenam:

- If you are allergic to glucosamine or any of the other components of this medication (listed in section 6).

- If you are allergic to seafood, as glucosamine is derived from seafood.

Warnings and precautions

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

- If you have impaired glucose tolerance. Frequent blood sugar level checks may be necessary when starting treatment with glucosamine.

- If you have any kidney or liver impairment, as no studies have been conducted in these conditions and therefore no dosage recommendations can be made.

- If you have any risk factors for heart or artery diseases, as in some cases, an increase in cholesterol has been observed in patients treated with glucosamine.

- If you have asthma. When starting treatment with glucosamine, be aware that symptoms may worsen.

- You should consult your doctor to rule out the presence of other joint diseases for which another treatment should be considered.

- Inform your doctor if you have diabetes mellitus.

Use of Acenam with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

Precaution is recommended when administering Acenam in combination with other medications, especially with:

• Some types of medications used to prevent blood clotting (e.g., warfarin, dicumarol, phenprocoumon, acenocoumarol, and fluindione). The effect of these medications may be potentiated if used with glucosamine. Therefore, patients treated with these combinations should be closely monitored at the start or end of treatment with glucosamine.
• Antibiotics such as tetracycline (medications for treating infections).

Consult your doctor.

Taking Acenam with food, drinks, and alcohol

You can take the tablets with or without food.

Pregnancy, breastfeeding, and fertility

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

Acenam should not be used during pregnancy.

Glucosamine is not recommended for use during breastfeeding.

Driving and operating machinery

No studies have been conducted on how Acenam affects the ability to drive and 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 medication contains 295 mg of sorbitol in each tablet.

This medication contains 318.2 mg of sodium (main component of table salt/for cooking) in each tablet. This is equivalent to 16% of the recommended daily maximum sodium intake for an adult.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

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

Acenam 1250 mg Effervescent Tablets are administered orally.

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

If you take more Acenam 1250 mg Effervescent Tablets than you should

Consult your doctor, pharmacist, go to the nearest hospital, or call the Toxicological Information Service, phone 91 562 0420, indicating the medication and the amount ingested.

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

If you forgot to take Acenam 1250 mg Effervescent Tablets

Do not take a double dose to compensate for the missed dose.

Take your dose as soon as possible. If there is little time left before taking the next dose, wait until then to take your tablet.

Take the next dose according to the usual schedule.

If you interrupt treatment with Acenam 1250 mg Effervescent Tablets

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

Symptoms may recur.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The most commonly observed are:

You should interrupt treatment with glucosamine and immediately consult your doctor if you experience symptoms of angioedema, such as:

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

The most frequently observed are:

Frequent (affects 1 to 10 of every 100 people)

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

Rare (affects 1 to 10 of every 1,000 people)

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

Unknown frequency (cannot be estimated from available data)

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use ACENAM after the expiration date marked on the tube or box after

the CAD abbreviation. The expiration date is the last day of the month indicated.

Store below 30°C.

Store in the original packaging to protect it from moisture.

Keep the container perfectly closed.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and medicines you no longer need at the SIGRE point of your pharmacy.In case of doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Acenam 1250 mg effervescent tablets

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

Appearance of the product and content of the packaging

Acenam 1250 mg effervescent tablets are presented in the form of effervescent tablets, white in color. Each package contains 30 tablets in 2 polypropylene tubes with polyethylene stoppers equipped with a desiccant (silica gel) containing each 15 effervescent tablets, 20 tablets in 1 tube of 20 effervescent tablets and packages of 40 tablets in two tubes of 20 effervescent tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Centrum Pharmaceutical Specialties, S.A.

C/ Sagitario, 14

03006 Alicante, Spain

Responsible for manufacturing

E Pharma Trento S.p.A.

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

Last review date of this leaflet:May 2018.

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).