Drolican 200 mg/250 mg hard capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Droglican 200 mg/250 mg hard capsules
Sodium chondroitin sulfate / Glucosamine hydrochloride
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 or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects not listed in this leaflet, see section 4.
Leaflet contents:
- What Droglican is and what it is used for
- What you need to know before taking Droglican
- How to take Droglican
- Possible side effects
- How to store Droglican
- Contents of the pack and other information
1. What Droglican is and what it is used for
Droglican is a hard capsule containing two active substances. One active substance is chondroitin sulfate and the other is glucosamine hydrochloride. Both active substances belong to the group of non-steroidal anti-inflammatory and antirheumatic agents.
Droglican is used in the treatment of symptoms of knee osteoarthritis in patients with moderate to severe pain in whom combined treatment with chondroitin sulfate and glucosamine is indicated.
2. What you need to know before taking Droglican
Do not take Droglican:
-
If you are allergic (hypersensitive) to chondroitin sulfate, glucosamine, or any of the other
components of this medicine (listed in section 6). -
If you are allergic to shellfish, as glucosamine is derived from shellfish.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Droglican.
-
If you have impaired glucose tolerance. More frequent monitoring of blood sugar levels may be necessary when starting treatment with glucosamine.
-
If you have any kidney or liver problems, as studies have not been conducted in this type of patient and therefore no dosage recommendations can be given.
-
If you suffer from a serious heart condition. Consult your doctor.
Children
The use of this medicine is not recommended in children or adolescents under 18 years of age.
Use of Droglican with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Caution is recommended when administering Droglican in combination with other medicines, especially:
- Certain types of 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 treated with these combinations should be monitored more carefully when starting or stopping glucosamine treatment.
- Medicines used to treat infections (antibiotics such as tetracycline, chloramphenicol, or penicillin).
Consult your doctor or pharmacist for further information.
Taking Droglican with food and drinks
You may take the capsules before, during, or after meals. However, if you frequently experience stomach discomfort when taking medicines, it is advisable to take Droglican after meals.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
It is unknown whether the active ingredients of Droglican pass into breast milk. Therefore, do not take this medicine if you are breastfeeding, as there are insufficient data regarding the safety for your baby.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines
If you experience dizziness or drowsiness, avoid driving or operating machinery.
3. How to take Droglican
Follow exactly the dosage instructions provided in this leaflet or those indicated by your doctor or pharmacist.
The recommended dose is 2 capsules 3 times a day.
The capsules should be swallowed whole, 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 headache, dizziness,
disorientation, joint pain, nausea, vomiting, or diarrhea, although you may not experience any
symptoms. In any case, inform your doctor.
In case of overdose or accidental ingestion, contact the Toxicology Information Service at
91 562 04 20 (indicating the medicine and the amount ingested).
If you forget to take Droglican
You may take the missed dose as soon as you remember, but do not take more than 6 capsules a day.
If you stop taking Droglican
Symptoms may reappear. If you have any further questions about the use of this product, consult your
doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Immediately inform your doctor if you experience any of the following adverse effects:
Respiratory tract infection, urinary tract infection, or chest pain.
The most commonly observed adverse effects with Droglican are:
Common (may affect up to 1 in 10 patients/people):
- headache
- diarrhoea, nausea, indigestion, flatulence (gas)
Rare (may affect up to 1 in 1,000 patients/people):
- disturbance of taste sensation
- stomach pain
- gastroesophageal reflux (a condition in which food or liquid flows back from the stomach into the oesophagus, the tube connecting the mouth to the stomach)
- constipation, acid reflux, abdominal distension
- ?muscle cramps, limb pain
- ?fatigue
- ?respiratory tract infection, urinary tract infection
- ?increased liver enzyme levels
- ?abnormalities in urine tests
Adverse effects observed in patients treated exclusively with chondroitin sulfate (and not previously described) are as follows:
Very rare (may affect up to 1 in 10,000 patients/people):
- oedema, fluid retention
- allergic-type reaction
Adverse effects observed in patients treated exclusively with glucosamine hydrochloride (and not previously described) are as follows:
Uncommon (may affect up to 1 in 100 patients/people):
- redness or skin rash and itching
Frequency not known (cannot be estimated from available data):
- swelling of the face, tongue, or throat
- urticaria, swelling / oedema of ankles, legs, and feet
- dizziness, vomiting
- worsening of blood glucose control in patients with diabetes mellitus
In general, the adverse effects that may occur during treatment with Droglican are mild in nature and disappear upon discontinuation of treatment.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Droglican
Do not store above 30°C. Keep in the original packaging to protect from moisture.
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to properly dispose of containers and unused medicines. This helps protect the environment.
6. Package contents and other information
Composition of Droglican
- The active substances are 200 mg of sodium chondroitin sulfate and 250 mg of glucosamine hydrochloride.
- The other component is magnesium stearate.
Appearance of the medicine and contents of the pack
Droglican is presented as turquoise hard gelatin capsules, size 1. Capsule contents: white or almost white powder.
It is packaged in a cardboard box containing 90 capsules arranged in aluminum and plastic (PVC/PVDC) blisters.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
LABORATORIO REIG JOFRE, S.A.
Gran Capitán, 10
08970 Sant Joan Despí (Barcelona), Spain.
Manufacturer:
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
Date of the most recent review of this leaflet: September 2022
Detailed information on this medicine is available on the website of the Spanish Medicines Agency: http://www.aemps.gob.es