Solpadeine tablets for pain and fever, N12
Paracetamol, codeine phosphate hemihydrate, caffeine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. This medicine is available without a prescription, but Solpadeine should be taken exactly as directed for best results.
- Do not throw this leaflet away as you may need to read it again.
- If you want to know more or consult, contact your pharmacist.
- If side effects occur (even if they are not listed in this leaflet), contact your doctor or pharmacist.
- If your condition has not improved or even worsened for 3 days, consult a doctor
What is this leaflet about?
1. What Solpadeine is and what it is used for
2. What you need to know before you take Solpadeine
3. How to take Solpadeine
4. Possible side effects
5. How to store Solpadeine
6. Contents of the pack and other information
1. What Solpadeine is and what it is used for
Indications
Solpadeine is intended for the relief of mild to moderate pain (joint, back, headache and migraine, menstrual, neuralgic and dental pain). To relieve cold and flu symptoms. Solpadeine tablets contain three active substances: paracetamol, which relieves pain and reduces fever, codeine phosphate and caffeine, which together provide fast and strong pain relief. This medicine contains codeine. Codeine belongs to a group of drugs called opioid analgesics. These drugs relieve pain. The drug can be used alone or together with other pain relievers, for example: paracetamol. Do not use the medicine for more than 3 days without consulting a doctor!
2. What you need to know before taking Solpadeine tablets for pain
Solpadeine tablets should not be used:
- if you are allergic to paracetamol, codeine phosphate hemihydrate, caffeine, pain-relieving opioids or any of the excipients of this medicine (they are listed in section 6);
- together with other medicines containing paracetamol;
- if you suffer from asthma and have asthma attacks;
- for children younger than 12 years;
- relieve pain in children and adolescents (0-18 years) after tonsillectomy for obstructive sleep apnea syndrome;
- if it is known that codeine is very quickly metabolized into morphine in your body;
- if you are breastfeeding.
Warnings and precautions
- Talk to your doctor or pharmacist before taking Solpadeine: if you have severe kidney or liver disease;
- if bowel function is impaired, including bowel stoppage;
- if your gallbladder was removed during surgery;
- if you are pregnant;
- if you are taking medication for depression or respiratory disorders;
- if you are taking medicines for nausea, vomiting or high blood cholesterol
Avoid consuming too many products that contain caffeine (such as coffee, tea and some energy drinks, usually in cans). Codeine is metabolized to morphine in the liver by an enzyme. Morphine is a substance that relieves pain. In some people, this enzyme is altered and works in a different way. Some people do not produce morphine or produce only very small amounts of morphine, so the pain relief is not sufficient. Other people are more likely to have severe side effects because of the very large amounts of morphine involved. You must stop using this medicine and seek medical help immediately if you notice any of the following side effects: shallow or shallow breathing, confusion, drowsiness, narrowing of the pupils, nausea or vomiting, constipation, loss of appetite.
In children and adolescents
Use in children and adolescents after surgery
Codeine should not be used for pain relief in children and adolescents after tonsillectomy for obstructive sleep apnea syndrome.
Use in children with respiratory problems
Codeine is not recommended for use in children with respiratory problems, as symptoms of morphine toxicity may be exacerbated in these children.
If the symptoms worsen or do not improve, it is necessary to consult a doctor. In order to relieve symptoms, the lowest dose of this medicine should be used for the shortest possible time. Long-term and regular use of this medicine can lead to addiction.
Other medicines and Solpadeine
Tell your doctor if you are taking any of the following medicines:
- metoclopramide or domperidone: medicines used to relieve unwellness;
- medicines that can make you feel sleepy or drowsy, including hypnotics, sedatives, tricyclic antidepressants, phenothiazine tranquilizers or alcohol;
- medicines called MAOIs (monoamine oxidase inhibitors);
- medicines used to thin the blood, such as warfarin.
Pregnancy and breast-feeding
It is necessary to consult a doctor or pharmacist before using any medicine. If you are pregnant, do not take this medicine unless your doctor tells you to do so. Codeine should not be used during breastfeeding. Codeine and morphine are excreted in breast milk.
Driving and operating machinery
Solpadeine may cause drowsiness or dizziness. If you feel dizzy or drowsy, do not drive or operate machinery.
Important information about some of the excipients of Solpadeine
This medicine contains carmosine (E122). May cause allergic reactions.
3. How to take Solpadeine tablets for pain
Always take this medicine exactly as your doctor has told you. If in doubt, ask your doctor or pharmacist.
Dosage: Adults and adolescents over 12 years of age
Take two Solpadeine tablets, if needed, up to four times a day. Do not take them more often than every four hours and do not take more than 4 doses (8 Solpadeine tablets) in any 24 hours. This medicine should not be used for more than 3 days. If the pain does not improve after 3 days, consult your doctor. Solpadeine should not be used in children under 12 years of age because of the risk of serious breathing problems.
The medicine contains codeine - anxiety and irritability may occur after long-term use and then discontinuation. If you need to continue using this medicine, talk to your doctor immediately. Do not take with other medicines containing paracetamol or codeine.
What to do if you overdose on Solpadeine?
When paracetamol is overdosed, it can cause liver failure and breathing problems. If you have taken more than the recommended dose of the medicine, contact your doctor immediately, even if you do not feel ill.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects of Solpadeine tablets
This medicine, like all medicines, can cause side effects, although not everybody gets them.
When using this medicine, you may experience:
- constipation.
Immediately stop taking the medicine and tell your doctor:
- if you have had your gallbladder removed in the past and after taking the medicine you started to have abdominal pain, nausea, or started vomiting;
- if allergic reactions have occurred, such as skin rash or itching, sometimes accompanied by difficulty breathing or swelling of the lips, tongue, throat or face;
- if a skin rash or flaking has occurred or ulcers have appeared in the mouth;
- if you have had breathing problems after taking aspirin or non-steroidal anti-inflammatory drugs in the past, and similar reactions have occurred after taking this drug;
- if you have unexplained bleeding or bruising.
These reactions are rare. Drinking a lot of tea or coffee while taking Solpadeine tablets may increase irritability and anxiety.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly by filling out the form on the website www.vvkt.lt, by mail to the State Medicines Control Service at the Ministry of Health of the Republic of Lithuania, Žirmūnų str. 139A, LT 09120 Vilnius, phone: 8 800 73568, fax 8 800 20131 or e-mail by mail NegeidaujamaR@vvkt.lt . By reporting side effects, you can help us get more information about the safety of this medicine.
5. How to store Solpadeine pain tablets
Keep out of sight and reach of children. Store at a temperature not higher than 25°C. Do not use this medicine after the expiry date stated on the blister and carton. The drug is suitable for use until the last day of the indicated month. Medicines must not be disposed of in the sewer or with household waste. Ask your pharmacist how to dispose of unnecessary medicines. These measures will help protect the environment.
6. Solpadeine package contents and other information
Composition of Solpadeine tablets
- The active ingredients of Solpadeine are paracetamol, codeine and caffeine. One tablet contains 500 mg of paracetamol, 8 mg of codeine phosphate hemihydrate and 30 mg of caffeine.
- Auxiliary ingredients of Solpadeine are pregelatinized starch, corn starch, potassium sorbate, povidone, microcrystalline cellulose, talc, stearic acid, magnesium stearate, hypromellose and carmosin (E122).
What Solpadeine looks like and contents of the pack
Capsule-shaped tablets with "Solpadeine" printed on one side in red. Solpadeine is supplied in a cardboard box or in a cardboard/PVC wallet containing PVC/aluminium foil blisters. The pack contains 12 Solpadeine tablets.