ACENAM 1250 mg EFFERVSCENT TABLETS

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

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 shellfish, since glucosamine is obtained from shellfish.

Warnings and precautions

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

• If you have altered sugar tolerance (glucose). More frequent monitoring of blood sugar levels may be necessary when starting treatment with glucosamine.
• If you have any kidney or liver impairment, since investigations have not been conducted in these conditions and therefore no dosage recommendations can be given.
• If you have any risk factors for heart or artery disease, as increased cholesterol has been observed in some patients treated with glucosamine.
• If you have asthma. When starting treatment with glucosamine, keep in mind that symptoms may worsen.
• You should consult your doctor to rule out the presence of other joint diseases for which other treatments should be considered.
• Inform your doctor if you have diabetes mellitus.

Using Acenam with other medications

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

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

Caution is recommended if Acenam is administered in combination with other medications, especially:

• Certain types of medications used to prevent blood clotting (e.g., warfarin, dicumarol, phenprocoumon, acenocoumarol, and fluindione). The effect of these medications may be enhanced 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, beverages, 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.

The use of glucosamine is not recommended during breastfeeding.

Driving and using machines

No studies have been conducted on how Acenam affects the ability to drive and use machines.

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) in each tablet, equivalent to 16% of the maximum recommended daily sodium intake for an adult.

3. How to take Acenam 1250 mg effervescent tablets

Follow the administration instructions for this medication exactly as indicated 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) in a single daily dose for symptom relief.

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

Acenam 1250 mg effervescent tablets are administered orally.

The tablets should be dissolved previously in half a glass of water. The resulting solution can be taken with or without food.

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

Consult your doctor, pharmacist, or go to the nearest hospital or call the Toxicology 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 forget to take Acenam 1250 mg effervescent tablets

Do not take a double dose to make up for forgotten 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 your next dose according to your usual schedule.

If you interrupt treatment with Acenam 1250 mg effervescent tablets

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

Symptoms may reappear.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The most commonly observed are:

You should interrupt glucosamine treatment and consult your doctor immediately 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:

Frequent (affects 1 to 10 of every 100 people)

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

Uncommon (affects 1 to 10 of 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 diabetes mellitus.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Acenam 1250 mg effervescent tablets

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

Do not use ACENAM after the expiration date stated on the tube or box after the abbreviation CAD. The expiration date is 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.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Acenam 1250 mg effervescent tablets

• The active ingredient of this medication 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 flavor, acesulfame K, and leucine.

Appearance of the product and package contents

Acenam 1250 mg effervescent tablets are presented in the form of white effervescent tablets. Each package contains 30 tablets in 2 polypropylene tubes with a polyethylene cap equipped with a desiccant (silica gel) containing 15 effervescent tablets each, 20 tablets in 1 tube of 20 effervescent tablets, and packages 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 last revision of this leaflet:May 2018.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).