Package Insert: Information for the User

Droglican 200 mg/250 mg Hard Capsules

Chondroitin Sulfate Sodium/Glucosamine, Hydrochloride

Read this package insert carefully before starting to take the medication, as it contains important information for you.

- Keep this package insert, as you may need to refer to it again.

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

- This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

- If you experience adverse effects not listed in this package insert, see section 4.

1. What is Droglican and for what it is used

2. What you need to know before starting to take Droglican

3. How to take Droglican

4. Possible adverse effects

5. Storage of Droglican

6. Contents of the package and additional information

Droglican is a hard capsule containing two active ingredients. One active ingredient is chondroitin sulfate and the other is glucosamine hydrochloride.

Both active ingredients belong to the group of non-steroidal anti-inflammatory and anti-rheumatic agents.

Droglican is used in the treatment of symptoms of knee arthritis in patients with moderate to severe pain in whom combined treatment with chondroitin sulfate and glucosamine is indicated.

Droglican is used in the treatment of symptoms of knee arthritis in patients with moderate to severe pain in whom combined treatment with chondroitin sulfate and glucosamine is indicated.

Glucosamine.

Do not take Droglican:

- If you are allergic (hypersensitive) to chondroitin sulfate, 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 or pharmacist before starting to take Droglican.

- If you have impaired glucose tolerance. Frequent monitoring of blood sugar levels may be necessary

when starting treatment with glucosamine.

- If you have any kidney or liver impairment, as no studies have been conducted in this type of patient

and therefore no dosage recommendations can be made.

- If you have a severe heart disease. Consult your doctor.

Children

This medication is not recommended for use in children or adolescents under 18 years of age.

Use of Droglican with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Caution is advised when administering Droglican in combination with other medications, particularly 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. Patients treated with these combinations should be closely monitored at the start or end of treatment with glucosamine.
• Medications for treating infections (antibiotics such as tetracycline, chloramphenicol, or penicillin).

Consult your doctor or pharmacist for more information.

Taking Droglican with food and drinks

You can take the capsules before, during, or after meals. However, if you often experience stomach discomfort when taking medications, it is recommended to take Droglican after meals.

Pregnancy and breastfeeding

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

The active principles of Droglican are unknown to pass into breast milk. Therefore, do not take this medication if you are breastfeeding, as there is insufficient data on the health of your baby.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

If you feel dizzy or drowsy, avoid driving or operating machinery.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist.

The recommended dose is 2 capsules 3 times a day.

The capsules must be swallowed without chewing with a sufficient amount of liquid.

If you take more Droglican than you should

If you have taken more capsules than you should, you may experience headaches, dizziness, disorientation, joint pain, nausea, vomiting, or diarrhea, although it is likely that you will not experience any symptoms. In any case, inform your doctor.

In case of overdose or accidental ingestion, consult the Toxicological Information Service at telephone 91 562 04 20 (indicating the medication and the amount ingested).

If you forgot to take Droglican

You can take the missed dose when you remember it but do not take more than 6 capsules a day.

If you interrupt treatment with Droglican

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Inform your doctor immediately if you experience any of the following side effects:

Respiratory tract infection, urinary tract infection, or chest pain.

The most commonly observed side effects with Droglican are:

Frequent (may affect up to 1 in 10 patients/people):

• Headache
• Diarrhea, nausea, indigestion, flatulence (gas)

Rare (may affect up to 1 in 1,000 patients/people):

• Alteration of taste
• Stomach pain
• Gastroesophageal reflux (a condition in which food or liquid is returned from the stomach to the esophagus, the tube that goes from the mouth to the stomach)
• Constipation, acidity, abdominal distension
• ?Muscle cramps, pain in a limb
• ?Fatigue
• ?Respiratory tract infection, urinary tract infection
• ?Increased levels of liver enzymes
• ?Abnormalities in urine analysis

The side effects observed in patients treated only with chondroitin sulfate (and not previously described) are as follows:

Very rare (may affect up to 1 in 10,000 patients/people):

• Edema, water retention
• Allergic reaction

The side effects observed in patients treated only with hydrochloride of glucosamine (and not previously described) are as follows:

Infrequent (may affect up to 1 in 100 patients/people):

• Redness or rash on some area of the skin and itching

Frequency not known (cannot be estimated from available data):

• Swelling of the face, tongue, or throat
• Urticaria, swelling/tumefaction of ankles, legs, and feet?
• Dizziness, vomiting
• Worsening of blood sugar control in patients with diabetes mellitus

Generally, the side effects that may appear during treatment with Droglican are of mild character and disappear with the suspension of treatment.

If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of side effects:

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

Do not store at a temperature above 86°F (30°C). Store in the original packaging to protect it from moisture.

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of unused containers and medications. By doing so, you will help protect the environment.

Composition of Droglican

• The active principles are 200 mg of sodium chondroitin sulfate and 250 mg of glucosamine hydrochloride.
• The other component is magnesium stearate.

Appearance of the product and contents of the packaging

Droglican is presented in the form of hard gelatin capsules, size 1, turquoise in color. Contents of the capsules: white or off-white powder.

It is packaged in a cardboard box containing 90 capsules conditioned in aluminum and plastic (PVC/PVDC) blisters.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona) Spain.

Responsible for manufacturing:

Noucor Health., S.A.

Avda. Camí Reial, 51-57

08184 Palau-solità i Plegamans (Barcelona) – Spain

or

Sincrofarm, S.L.

c/ Mercuri, 10. Pol. Ind. Almeda

08940 Cornellà de Llobregat (Barcelona), Spain

Last review date of this leaflet September 2022

The detailed information on this medication is available on the website of the Spanish Agency for Medicines:http://www.aemps.gob.es