Dolocalma belongs to the pharmacotherapeutic group 2.10 – Analgesic and antipyretic drugs.

Dolocalma has analgesic action (against pain), anti-inflammatory action (treatment of inflammation) and antipyretic action (to treat fever).

Like most non-steroid anti-inflammatory drugs, the analgesic and anti-inflammatory action of Dolocalma is due to its capacity to inhibit the production of chemical substances that act as mediators of pain and inflammation.

Its effect on fever is due to its action at the level of the centre for regulation of body temperature.

Why has my doctor prescribed me Dolocalma?

Your doctor has prescribed you Dolocalma for the relief of acute severe pain symptoms or severe spasmodic pain (biliary, kidney and lower urinary duct colic), tumour pain, or because you presented high fever resistant to other antipyretic drugs.

Dolocalma must not be used in mild pain situations.

Before taking this medicine, please read section “How to take Dolocalma”.

Do not take Dolocalma

• if you have allergy (hypersensitivity) to the active substance or any of the other ingredients of this medicine
• If you are in the third trimester of pregnancy
• If you have been diagnosed with porphyria (a disease characterised by a change in the production of haemoglobin and other substances and that manifests by sensitivity to light that causes skin eruptions, neuropsychiatric changes and changes in internal organs, namely abdominal pain and colic)
• If you suffer from aplastic anaemia (blood disease characterised by the difficulty of the body in producing blood cells)
• If you suffer from gastric problems, namely gastric ulcers or duodenal ulcers
• If you have already experienced symptoms of asthma (shortness of breath), rhinitis (inflammation of the nose membrane), urticaria (skin allergy characterized by red spots in the skin, being very itchy), angioedema (a type of urticaria which occurs deeper in the skin, characterised by swelling and sensation of pain or burn) and/or anaphylactic shock (severe adverse reaction) when taking medicines containing the same active substance as Dolocalma, or after having taken medicines containing acetylsalicylic acid, paracetamol or other non-steroid anti-inflammatory drugs.
• If you have been told by your doctor that you have any enzymatic deficiency. Talk to your doctor before taking this medicine.

If you think any of these situations apply to you, do not take this medicine. Talk to your doctor immediately and follow his instructions.

Warnings and precautions

Talk to your doctor or pharmacist before taking Dolocalma.

Before starting treatment with Dolocalma, tell your doctor about any health conditions you have or may have had, particularly:

• If you have allergies
• If you suffer from hepatic disease (liver)
• If you suffer from any type of blood disorders

The treatment must be stopped immediately at the first sight of symptoms or signs of:

• Anaphylaxis (inflammation of the mouth and throat or of the anal and genital area, hoarseness, difficulty in swallowing, sore throat, tachycardia, low blood pressure, itchy skin or reddening of the skin together with a feeling of pain or burn sensation)
• Agranulocytosis (symptoms of infection, high fever and chills). The risk of occurrence of anaphylactic shock seems to be higher with injectable administration and so it must be carried out slowly, with greater precaution in patients with low blood pressure and cardiovascular problems

Severe cutaneous adverse reactions

Severe cutaneous adverse reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with the treatment with metamizole. Stop using metamizole immediately and talk to a doctor if you notice any of the symptoms related to these severe cutaneous adverse reactions described in section 4.

If you have ever developed severe cutaneous reactions you must not resume treatment with Dolocalma at all (see section 4).

Drug-induced liver injury

Cases of liver inflammation have been reported in patients treated with metamizole with an onset of few days to few months following treatment initiation. Stop using Dolocalma and talk to your doctor immediately if you have symptoms related to liver problems, such as motion sickness feeling (nausea or vomiting), fever, fatigue, loss of appetite, dark-coloured urine, light-coloured faeces, yellow skin or yellowing of the white area of the eyes, itching, cutaneous eruption or pain in the upper area of your abdomen. Your doctor will check the functioning of your liver.

You must not take Dolocalma if you have already taken any medicine containing metamizole and developed liver problems.

Other medicines and Dolocalma

Tell your doctor if you are taking, have recently taken or might take any other medicines.

• Bupropion, a medicine used in the treatment of depression or used as an adjuvant in quitting smoking
• Efavirenz, a medicine used in the treatment of HIV/AIDS
• Methadone, a medicine used to treat dependency on illegal drugs (so-called opioids)
• Valproate, a medicine used in the treatment of epilepsy or bipolar disorder
• Tacrolimus, a medicine used to prevent the rejection of organs in transplant patients
• Sertraline, a medicine used in the treatment of depression

When taking Dolocalma concomitantly with other painkillers, hypnotic drugs (medicines used in sleep disorders), or barbiturates (sedatives) its action can be increased.

Dolocalma must not be taken together with medicines containing chlorpromazine (antipsychotic medicine) because it may lead to a decrease in body temperature, nor ciclosporin since it may lead to a decrease of your blood levels.

Dolocalma with food, drink and alcohol

When taken at the same time, Dolocalma may interfere with alcoholic beverages.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Available data on the use of metamizole during the first three months of pregnancy is limited but do not indicate harmful effects to the embryo. In selected cases when no other treatment options exist, single doses of metamizole during the first and second trimester might be acceptable after consultation with your doctor or pharmacist and after the benefits and risks of metamizole use have been carefully weighed up. However, in general, the use of metamizole during the first and second trimester is not recommended.

During the last three months of pregnancy, you must not take Dolocalma because of an increased risk of complications for the mother and child (haemorrhaging, premature closure of an important blood vessel, the so-called Ductus Botalli, of the unborn, which naturally closes only after birth).

Breast-feeding

The breakdown products of metamizole pass into breast milk in considerable amounts and a risk to the breastfed infant cannot be excluded. Especially the repeated use of metamizole during breastfeeding must therefore be avoided. In case of a single administration of metamizole, mothers are advised to collect and discard the breastmilk for 48 hours after the dose.

Do not take Dolocalma if you are pregnant, think you may be pregnant, or if you are breast-feeding.

Driving and using machines

Dolocalma does not cause drowsiness or depression, and therefore should not interfere in your ability to drive and operate machinery.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage is determined by the intensity of the pain or fever and individual sensitivity of response to Dolocalma.

It is essential to choose the lowest dose that controls pain and fever. Your doctor will tell you how to take Dolocalma.

The recommended dose is as follows:

Adults and adolescents of 15 years of age or older (> 53 kg) can take 575 mg metamizole as a single dose, which can be taken up to 6 times daily at intervals of 4 – 6 hours corresponding to a maximum daily dose of 3,450mg.

A clear effect can be expected 30 to 60 minutes after oral administration.

Dolocalma is not recommended for children younger than 15 years of age. Other forms and strengths of this medicine are available for younger children; ask your doctor or pharmacist.

Capsules must be taken with meals.

The duration of treatment must rely on doctor indications.

Elderly and patients in poor general health/with renal impairment

The dose should be reduced in elderly people, in debilitated patients and in those with reduced renal function, as excretion of the breakdown products of metamizole may be delayed.

Patients with impaired kidney or liver function

As the rate of elimination is reduced in patients with impaired kidney or liver function, repeated high doses should be avoided. No dose reduction is required with short-term use only. There is no experience available with long-term use.

If you take more Dolocalma than you should

If by mistake you have taken more capsules than you should, you must tell your doctor immediately. In these situations, treatment must focus on emptying the stomach, through vomiting, or by means of gastric lavage. Haemoperfusion with adsorbent material or forced diuresis can also be considered.

If you forget to take Dolocalma

Do not take a double dose to make up for a forgotten dose. Resume treatment by taking the capsule normally within the next scheduled time. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using Dolocalma and tell your doctor immediately if you experience any of the following symptoms:

Motion sickness feeling (nausea or vomiting), fever, fatigue, loss of appetite, dark-coloured urine, light-coloured faeces, yellow skin or yellowing of the white area of the eyes, itching, cutaneous eruption or pain in the upper area of your abdomen. These symptoms may indicate liver damage. Also see section 2 “Warnings and precautions”.

Allergic reactions on the skin and in mucous membranes may also occur. Very rarely, severe skin reactions have occurred, which can be fatal, and that require immediate suspension of the treatment with Dolocalma.

Some patients have reported cases of oliguria (decrease in the amount of urine eliminated) or anuria (complete inhibition of the elimination of urine), proteinuria (excretion of proteins in urine) and interstitial nephritis (inflammation of the kidneys), particularly in dehydrated patients and in patients with impaired renal function.

Unknown frequency (frequency cannot be estimated from the available data):

Liver inflammation, yellowing of the skin and of the white area of the eyes, increased blood levels of liver enzymes.

Agranulocytosis and anaphylactic shock may also occur (as mentioned in section “What you need to know before you take Dolocalma”, in section “Do not take Dolocalma”).

Severe cutaneous adverse reactions

Stop taking metamizole and immediately talk to your doctor if you notice any of the following severe undesirable effects:

• Reddened areas of the skin, not swollen, target-shaped or in the shape of a circle, in the torso, often with blisters in the center, scaling of the skin, ulcers in the mouth, throat, nose, genitals or in the eyes. These severe cutaneous eruptions may be preceded of fever and flu-like symptoms (Stevens-Jonhson syndrome, toxic epidermal necrolysis)
• Generalised skin eruption, increased body temperature, increased lymph nodes (DRESS syndrome or hypersensitivity to medicines syndrome).

The administration of high doses of Dolocalma may originate a red coloration of urine, due to the elimination of a product resulting from the transformation of the active substance by the body, which disappears with the suspension of the treatment.

If any of the side effects worsens, or if you get any side effects not mentioned in this leaflet, talk to your doctor or pharmacist. It will be a great help if you take note of what you felt, when it started and the time it lasted.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the contacts listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

website: http://www.infarmed.pt/web/infarmed/submissaoram

(preferably)

Or through the following contact details:

Direção de Gestão do Risco de Medicamentos

Parque da Saúde de Lisboa, Av. Brasil 531749-004 Lisboa

Tel: +351 21 798 73 73

Medicine hotline: 800222444 (free)

E-mail: farmacovigilancia@infarmed.pt

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

Do not store above 25ºC.

Store in the original package to protect from moist and light.

It is not recommended to remove the capsules from the blister before taking them nor place the capsules in another box, where they can be confused with other medicines.

Do not use this medicine after the expiry date which is stated on the blister pack and outer carton after “VAL”. The expiry date refers to the last day of that month.

Do not use this medicine if you notice any visible signs of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Dolocalma contains

• The active substance of this medicine is metamizole magnesium. Each capsule contains 575 mg of metamizole magnesium.
• The other ingredients are: magnesium stearate and talc.

What Dolocalma looks like and contents of the pack

Dolocalma is presented in the pharmaceutical form of:

– capsules, in blister packs of 10 capsules. Size packs of 10, 20, 60 or 200 (hospital use package) capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

SIDEFARMA – Sociedade Industrial de Expansão Farmacêutica, S.A.

Rua da Guiné, n.º 26

2689-514 Prior Velho

Portugal

Tel: 219426100

Fax: 219416205

e-mail: geral@sidefarma.pt

Should you need any other information on this medicine, please contact the Marketing Authorization Holder.

Medicinal product subject to medical prescription.

This leaflet was last revised in March 2024.