PATIENT INFORMATION LEAFLET

Dolalgial clonixino lisina 125mg coated tablets

Clonixino lisina

Dolalgial is an analgesic medication that belongs to a group of medications known as nonsteroidal anti-inflammatory drugs. It is an effective medication for reducing pain.

Dolalgial is indicated for symptomatic relief of mild to moderate pain in adults, such as headache, dental pain, menstrual pain, muscle pain (spasms) or lower back pain (lumbago).

Do not take Dolalgial

- if you are allergic (hypersensitive) to clonixin lysine or any other component of Dolalgial.

- if you have an active stomach ulcer.

- if you have blood cell formation disorders.

- if you have severe kidney insufficiency.

- if you have a tendency to suffer from digestive hemorrhages.

- if you are pregnant or breastfeeding (see the pregnancy and breastfeeding section).

Warnings and precautions

Consult your doctor or pharmacist before taking Dolalgial if:

- if you have a history of gastrointestinal disorders, stomach ulcers or inflammatory bowel disease, especially if you use clonixin lysine at high doses (4 tablets a day).

- if you have mild to moderate kidney function impairment.

- if you have any heart disorder.

- if you have a history of hypersensitivity (allergy) to anti-inflammatory drugs, history of asthma attacks, as well as skin eruptions or acute rhinitis.

- if you consume non-steroidal anti-inflammatory drugs at very high doses.

- if you have liver function impairment.

- clonixin lysine may cause difficulty getting pregnant. Inform your doctor if you plan to get pregnant or have difficulty getting pregnant.

Consult your doctor, even if any of the above circumstances have occurred at any time.

Children and adolescents

Do not use in children under 18 years old, without consulting a doctor.

Use of Dolalgial with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

Certain medications may interact with Dolalgial, in these cases it may be necessary to change the dose or discontinue treatment with one of the medications, so they should not be used without consulting a doctor.

This is especially important in the case of:

- Lithium salts (used in the treatment of depression).

- Anti-hypertensive medications (used to treat high blood pressure).

- Diuretics (medications that increase urine secretion).

- Non-steroidal anti-inflammatory drugs.

- Glucocorticoids (medications used in the treatment of inflammation).

- Ticlopidine, heparin and thrombolytics (medications that prevent blood clot formation).

- Methotrexate (used to treat cancer and rheumatoid arthritis).

Use of Dolalgial with food, drinks and alcohol

Do not take it with alcohol as it increases the risk of ulcers.

Take it preferably with meals.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy:

Do not take Dolalgial during the first and second trimester of pregnancy.

This medication is contraindicated during the third trimester.

Breastfeeding:

Do not recommend the administration of this medication to women in the lactation period, as clonixin lysine passes into breast milk.

Driving and operating machinery

During treatment, avoid situations that require a special state of alertness, such as driving vehicles or operating hazardous machinery, as clonixin lysine may decrease reaction time. Therefore, try not to perform tasks that may require special attention, until you know how you tolerate the medication.

Follow exactly the administration instructions for Dolalgial as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Dolalgial is administered orally. The tablets must be swallowed whole without being broken or chewed, accompanied by 1 glass of liquid, preferably water. Administration should be done together with meals to reduce possible stomach discomfort.

Adults (18 years and older):

The usual dose is 1 or 2 tablets up to 3 times a day, according to the intensity of the pain, with a maximum of 6 tablets per day (750 mg of clonixin lysine per day).

Use in children and adolescents:

Do not use in minors under 18 years, without consulting the doctor.

Patients over 65 years:

Treatment will be used with caution, following the doctor's instructions.

Patients with kidney diseases:

Treatment will be used with caution, following the doctor's instructions.

Patients with liver diseases:

Treatment will be used with caution, following the doctor's instructions.

The administration of this medication is subject to the appearance of painful symptoms. As these symptoms disappear, the medication should be discontinued.

The duration of this treatment depends on the type of pain, intensity, and evolution of the disease. If the pain persists for more than 10 days or other symptoms appear, treatment should be interrupted and the doctor consulted.

If you take more Dolalgial than you should:

If the recommended doses are exceeded, headaches, dizziness, tremors, abdominal pain, nausea, and vomiting may occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

In case of massive ingestion, a gastric lavage and symptomatic treatment will be performed.

If you forgot to take Dolalgial:

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

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

Like all medications, thismedicationcan produce adverse effects, although not all people will experience them.

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

• Discomfort
• Stomach pain
• Nausea
• Vomiting
• Diarrhea
• Mild intestinal bleeding.

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

• Stomach inflammation
• Vomiting with blood.

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

• Dizziness
• Reactions of hypersensitivity (allergy) with skin rash and sensation of skin itching.
• Eczema with patches
• Skin alterations.
• Alterations of the blood such as: agranulocytosis (decrease in white blood cells), anemia or thrombocytopenia (decrease in platelet count)
• Bronchospasm (sudden sensation of choking)
• Respiratory difficulties
• Insomnia
• Shortness of breath
• Trembling
• Pharyngitis
• Fever
• Fatigue
• Loss of appetite.

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

Adverse Effect Reporting:

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 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 on the safety of this medication.

Keep out of sight and reach of children.

Conservein its original packaging to protect it from moisture and do not store at a temperature above 30?°C.

Do not use Dolalgial after the expiration date that appears on the packaging 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. Disposeof the packaging and medicines that you no longer need at the SIGREcollection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Dolalgial

The active principle is clonixin lysine. Each tablet contains 125 mg of clonixin lysine.

The other components are: pregelatinized cornstarch, microcrystalline cellulose, magnesium stearate, colloidal silica, sepifilm 820 white (hypromellose, triacetin, titanium dioxide (E-171) and talc).

Appearance of the product and contents of the packaging

Dolalgial are coated tablets, white in color, round, and have the letter “D” engraved on one face.

They are presented in a blister pack containing 20 coated tablets.

Holder of the authorization and responsible for manufacturing:

Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

Spain

Responsible for manufacturing:

sanofi-aventis, S.A.

Ctra. La Batlloria a Hostalrich, km. 63,09

17404 - Riells i Viabrea (Girona)

Spain

Last review date of this leaflet: December 2021

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