Solpadeine Effervescent Tablets – 12 Count | Fast Pain Relief with Paracetamol, Codeine & Caffeine

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MARKETING AUTHORISATION NO. 3400/2011/01-02-03-04-05 Annex 1''
Leaflet
LEAFLET: INFORMATION FOR THE USER
Solpadeine 500 mg/8 mg/30 mg effervescent tablets
Paracetamol/ Codeine phosphate hemihydrate/ Caffeine anhydrous
Read all of this leaflet carefully before you start taking this medicine,
because it contains important information for you.
Always take this medicine exactly as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need any further information or advice.
- If you get any side effects, talk to your doctor or pharmacist.
These include any possible side effects not listed in this leaflet. See section 4.
- If you do not feel better or if you feel worse after 3 days, you should see a doctor.
What is in this leaflet:
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
Solpadeine contains 3 active substances: paracetamol used as an analgesic (pain reliever) and
antipyretic (fever reducer), codeine phosphate used as an analgesic and caffeine, for rapid relief of moderate to severe pain.
This medicine contains codeine. Codeine belongs to a class of medicines called opioid analgesics, which relieve pain by their action. It can be used alone or in combination with other painkillers, such as paracetamol.
Codeine can be used for a short period of time in adolescents over 12 years of age, to relieve moderate pain, which is not relieved by other painkillers, such as paracetamol
or ibuprofen taken alone.
Acting on your body in different ways, paracetamol and codeine combine
to relieve pain, and caffeine increases the analgesic effect of paracetamol.
Solpadeine is indicated for the short-term symptomatic treatment of moderate to severe pain, with various locations: headache, migraine, toothache, muscle or joint pain, neuralgia, pain in the ENT sphere (sore throat, sinus pain) or in case of painful menstruation.
Solpadeine is also indicated for the symptomatic treatment of fever from colds and flu.
2. What you need to know before you use Solpadeine
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Do not use Solpadeine
- if you are allergic (hypersensitive) to paracetamol, caffeine, codeine, other opioid analgesics
or any of the other ingredients of this medicine (listed in section 6);
- in children under 12 years of age,
- if you have bleeding disorders or other diseases with a risk of bleeding;
- if you have liver disease;
- if you have severe kidney problems;
- if you have digestive bleeding,
- if you have bronchial asthma, increased tracheobronchial secretions or severe breathing problems
(due to the presence of codeine),
- in case of head injuries and high intracranial pressure (for example as a result of
cerebral hemorrhage or brain tumors);
- if you have acute infectious diarrhea;
- if you suffer from sub-occlusion or intestinal obstruction (a condition in which the muscles of the intestines do not allow food to move through them, resulting in a blockage in the intestine);
- if you have had surgery on the liver, gallbladder or bile duct
(biliary tract);
- if you are taking medicines to treat depression called MAOIs (monoamine oxidase inhibitors - medicines to treat depression) or have taken such medicines
in the last 2 weeks;
- in case of acute alcoholism (due to the presence of codeine);
- if the patient is in a coma (opioid analgesics, e.g. codeine, should not be administered);
- if you know that you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase;
- if you are pregnant or breastfeeding;
- in respiratory depression, chronic constipation;
- for the relief of pain in children and adolescents (aged 0-18 years) after removal of the tonsils or adenoid vegetations (polyps) for the treatment of obstructive sleep apnea syndrome;
- if you know that you metabolize codeine very quickly to morphine;
Warnings and precautions
Please ask your doctor or pharmacist for advice:
Because it contains paracetamol
- if you frequently consume large amounts of alcohol;
- if you suffer from liver or kidney problems;
- if you have pre-existing liver damage (increased risk of hepatotoxicity) (due to the presence of
paracetamol);
Because it contains codeine
- if you suffer from cardiovascular problems (irregular heartbeat, high blood pressure),- used in high doses and for a long time, it may develop dependence and symptoms such as insomnia or irritability when stopping the medication; this medication should be administered in the lowest dose, for the shortest time possible to improve the symptoms. Routine and long-term use, unless it is done under medical supervision, may lead to physical and psychological dependence.
- if you have undergone gallbladder surgery, codeine may cause an acute abdominal pain syndrome, biliary or pancreatic type;
- if you suffer from any intestinal disorders, including intestinal obstruction;
- if you have a productive cough, codeine may prevent the elimination of tracheobronchial secretions. Caution is required in patients with limited respiratory function, pulmonary emphysema, pulmonary fibrosis, chronic obstructive pulmonary disease, bronchiolitis, severe tuberculosis, thoracic trauma (codeine depresses breathing and interferes with the compensatory mechanisms triggered by the deficiency of pulmonary ventilation). In asthmatics it may worsen obstructive phenomena (favors bronchospasm). - precautions are required in the following cases: in elderly or physically debilitated people, with cranial injuries, increased intracranial pressure, adrenal insufficiency, myasthenia gravis, acute abdomen, low blood pressure, hypothyroidism, prostatic hypertrophy or urethral strictures, chronic constipation. - use is not recommended in patients with ulcerative colitis (it may cause toxic dilatation of the colon). Use should also be avoided in patients with pancreatitis. Hypovolemia, chronic cor pulmonale, acute myocardial infarction, shock favor hypotensive accidents. The risk of convulsions may be increased when codeine is administered to patients with cerebral edema and to epileptics. Confusional states may be aggravated. Codeine is converted into morphine by an enzyme in the liver. Morphine is a substance that causes pain relief. Some people have a different version of this enzyme, and this can affect them in different ways. In some people, no morphine is produced or is produced in very small quantities and sufficient pain relief will not occur. Other people are more prone to serious side effects, because a very large amount of morphine is produced. If you notice any of the following side effects, you should stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, small pupils, feeling or being sick, constipation, loss of appetite.
Children and adolescents
Use in children and adolescents after surgery
Codeine should not be used to relieve pain in children and adolescents after removal of the tonsils or adenoid growths (polyps) for the treatment of obstructive sleep apnea syndrome.
Use in children with breathing problems
Codeine is not recommended for children with breathing problems, as the symptoms of morphine toxicity may be more severe in these children.
Because it contains caffeine
- do not drink excessive amounts of coffee and tea during treatment (due to the presence of caffeine).

Related to Solpadeine
Do not use other medicines containing paracetamol, caffeine and codeine at the same time.
This medicine should be taken in the lowest dose, for the shortest time necessary to relieve symptoms. Regular, prolonged use, unless under medical supervision, may lead to physical and psychological dependence (addiction).
It should not be taken for more than 3 days without medical advice.
Do not exceed the recommended daily dose.
Athletes should be warned that this medicine contains an active ingredient that can induce a positive result in anti-doping tests.
Solpadeine with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Solpadeine and other medicines taken at the same time may influence each other.
Do not take it with other medicines containing paracetamol, codeine or caffeine.
Related to paracetamol
Because it contains paracetamol, the effect of the treatment may be influenced if it is administered
concomitantly with:
 other medicines containing paracetamol;
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 warfarin or coumarin derivatives (medicines called anticoagulants which are used to
thin your blood);
 medicines with an inducing effect on liver enzymes (phenobarbital, phenytoin,
carbamazepine, rifampicin);
 alcohol consumption (chronic consumption);
 cholestyramine (bile acid binding resin used to treat high blood cholesterol);
 metoclopramide and domperidone (used in the treatment of gastrointestinal disorders);
 zidovudine,
 probenecid
 chloramphenicol (interaction possible especially in patients suffering from malnutrition).
Related to caffeine
 barbiturates or antihistamines;
 decongestants;
 oral contraceptives;
 cimetidine;
 disulfiram;
 ephedrine;
 enoxacin, ciprofloxacin and norfloxacin;
 ergotamine.
Related to codeine
 drugs for the treatment of depression, hypnotics, sedatives, tricyclic antidepressants, MAOIs,
phenothiazines;
 metoclopramide and domperidone (used in the treatment of gastrointestinal disorders);
 the combination of codeine with expectorant medication favors the blockage of tracheobronchial secretions,
so that they can no longer be eliminated.

If you are going to have certain laboratory investigations, inform your doctor that you are taking this medicine, as falsely low blood sugar values determined by the oxidase/peroxidase method or a falsely high serum uric acid values determined by the phosphotungstic test may occur. Increases in prothrombin time and serum bilirubin, lactate dehydrogenase and serum transaminase values indicate toxic liver damage. Solpadeine with food and drink Excessive consumption of coffee, tea or other energy drinks together with the use of Solpadeine may cause a feeling of tension and irritation, therefore caution is required when taking the medicine. Alcoholic beverages should be avoided during treatment. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Epidemiological studies in pregnant women have not revealed any toxic effects of paracetamol at the recommended doses, however codeine is not recommended during pregnancy. Therefore, Solpadeine is not recommended during pregnancy.
Breastfeeding
Paracetamol and caffeine are excreted in breast milk, but not in clinically significant quantities.
Do not take codeine during breast-feeding. Codeine and morphine pass into breast milk.
Driving and using machines
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Solpadeine may cause dizziness or drowsiness. You should not drive or use machines until you know how this medicine affects you.
Solpadeine contains sorbitol and sodium
Solpadeine contains sorbitol (E 420). If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking/using this medicine.
Solpadeine contains 398 mg sodium per effervescent tablet. This should be taken into account by
patients on a controlled sodium diet.
3. How to use Solpadeine
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Talk to your doctor or pharmacist if you are not sure.
Oral use.
Adults, elderly patients (with normal liver and kidney function) and adolescents aged 12 years and over:
The usual dose is 1-2 Solpadeine effervescent tablets taken orally, after dissolving in
water; if necessary, the dose can be repeated at intervals of 4-6 hours, without exceeding 4 doses per day (8
tablets in 24 hours).
Do not take at intervals of less than 4 hours.
Do not exceed the recommended doses.
Children:
Solpadeine should not be given to children under 12 years of age, due to the risk of severe breathing problems.
Duration of treatment
This medicine should not be taken for more than 3 days. If the pain does not improve after
3 days, contact your doctor for advice
How to take
The tablets should be completely dissolved in at least half a glass of water.
If you take more Solpadeine than you should
If you have taken more tablets than the recommended dose, contact your doctor immediately or
go to the emergency room of your nearest hospital. It is important to tell your doctor, even if
you feel well. In case of an overdose there is a risk of serious liver damage and respiratory problems.
If you forget to take Solpadeine
Do not take a double dose to make up for a forgotten dose.
Do not exceed the recommended dose. If you have exceeded the recommended dose, contact your doctor even if you do not feel sick.

If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
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Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine:
-if you have no more bile (after cholecystectomy) and you suffer from severe abdominal pain, nausea and vomiting,
-if you have allergic reactions, rash or itching, sometimes accompanied by difficulty in breathing or swelling of the lips, tongue, throat or face,
-if you have itching, peeling skin or mouth ulcers,
-if you have ever had breathing problems when taking aspirin or other non-steroidal anti-inflammatory drugs and now have a similar reaction when using this medicine,
-if you have unexplained bruising or bleeding.
When the combination paracetamol/caffeine/codeine is taken at the recommended doses with food containing caffeine, the resulting caffeine overdose may increase the potential for caffeine-related adverse reactions (insomnia, agitation, unreasonable fear, irritability, headache, gastrointestinal disturbances and palpitations).
The following adverse reactions have been reported:
Rare (affects less than 1 in 1000 users):
 allergies.
Very rare (affects less than 1 in 10,000 users):
 decrease in the number of white blood cells responsible for blood clotting,
 narrowing of the airways (especially in patients who are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs),
 severe allergic reactions,
 liver disorders,
 rash,
 itching of the skin,
 sweating,
 appearance of small red spots on the skin,
 temporary red rash with or without itching,
 severe allergic reaction characterized by swelling of the extremities, difficulty breathing and feeling sick,
 cloudy urine,
 a severe skin reaction called toxic epidermal necrolysis (TEN),
 drug rash,
 a severe skin reaction called Stevens Johnson syndrome (SJS),
 nervousness,
 dizziness.
Not known (frequency cannot be estimated from the available data):
 constipation,
 nausea,
 vomiting,
 dyspepsia,
 dry mouth,
 acute pancreatitis (in patients with a history of cholecystectomy),
 dependence occurs at high doses over prolonged periods,
 worsening of headache after prolonged use,
 drowsiness,
 itching of the skin,
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 profuse sweating,
 difficulty urinating.

Excessive consumption of coffee or tea during treatment with Solpadeine may cause irritability and
high blood pressure.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system, details of which are published on the website of the National Agency for Medicines and Medical Devices http://www.anm.ro/.
By reporting side effects, you can help provide additional information on the safety of this medicine.
5. How to store Solpadeine
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.
Store below 25°C, in the original packaging.
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.
6. Contents of the pack and other information
What Solpadeine contains
- The active substances are paracetamol, caffeine and codeine. One tablet contains paracetamol 500mg, caffeine anhydrous 30mg and codeine phosphate hemihydrate 8mg.
- The other ingredients are: sodium hydrogen carbonate, sorbitol powder, sodium saccharin, sodium lauryl sulphate, citric acid anhydrous, sodium carbonate anhydrous, povidone, dimethicone, purified water.
What Solpadeine looks like and contents of the pack
Solpadeine is available as flat, round, white tablets with a break line on one side.