Dicloalgan 12.5 mg soft capsules – patient leaflet, side effects, dosage

1. What Dicloalgan is and what it is used for

Dicloalgan contains the active substance diclofenac epolamine.

Dicloalgan is a medicine belonging to a group of non-steroidal anti-inflammatory drugs (NSAIDs). This medicine is a pain reliever which can also reduce inflammation and swelling.

Dicloalgan is used to provide short-term symptomatic relief in the following situations: mild to moderate pain (such as headache, dental pain, period pain, rheumatic pain and muscular pain).

2. What you need to know before you take Dicloalgan

DO NOT take Dicloalgan if:

• you are allergic to

  • diclofenac epolamine or any of the other ingredients of this medicine (listed in section 6)
  • diclofenac, acetylsalicylic acid or any other non-steroidal anti-inflammatory drug (NSAID)
• you currently have a gastric (stomach) or duodenal (intestinal) ulcer, bleeding or perforation
• you have unexplained blood-forming disorders
• you have a history of bleeding in the digestive tract or perforation, related to previous NSAIDs therapy
• you have had two or more episodes of gastric (stomach) or duodenal (intestinal) ulcer, or bleeding in the digestive tract (this can include blood in vomit, bleeding when emptying bowels, fresh blood in faeces or black, tarry faeces)
• you have established heart disease and/or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages
• you have or have had problems with your blood circulation (peripheral arterial disease)
• you have severe kidney, liver or cardiac failure
• you are more than six months pregnant (see also ‘Pregnancy, breast-feeding and fertility’)
• you are under 14 years old.

If any of the above applies to you talk to your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking Dicloalgan if you:

• think you may be allergic to diclofenac, aspirin, ibuprofen or any other NSAID. Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, chest pain, runny nose, skin rash or any other allergic type reaction.

• suffer from or have a history of any stomach or bowel disorders including ulcerative colitis or

  Crohn’s disease

• are elderly
• have kidney or liver problems
• have a condition called porphyria
• suffer from any blood or bleeding disorder
• have ever had asthma
• are breast-feeding
• have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides
• have diabetes
• are a smoker
• have recently had surgery
• are at risk of being dehydrated (e.g. by sickness or diarrhoea)
• recently had or you are going to have a surgery of the stomach or intestinal tract before receiving/taking/using Dicloalgan, as Dicloalgan can sometimes worsen wound healing in your gut after surgery.

This is because Dicloalgan might not be the right medicine for you.

• Because it is an anti-inflammatory medicine, the active substance in Dicloalgan may mask the signs and symptoms of infection. If you feel unwell and need to see a doctor, remember to tell him or her that you are taking Dicloalgan.

Cardiovascular disease

Medicines such as Dicloalgan may be associated with a small increased risk for heart attack (“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

Make sure your doctor knows, before you are given Dicloalgan

• if you smoke
• if you have diabetes
• if you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides

Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.

Children and adolescents

Children and adolescents under 14 year old must not take Dicloalgan (see also ‘Do not take Dicloalgan’).

Other medicines and Dicloalgan

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

Consult your doctor before taking Dicloalgan if you use any of the following medicines:

• Digoxin (a medicine for strengthening the heart), phenytoin (a medicine for treating epilepsy) or lithium (a medicine for treating mental disorders). Dicloalgan can increase the concentration of these substances in the blood.
• Water pills and medicines to lower blood pressure (diuretics and antihypertensives). Dicloalgan can weaken the effect of these medicines.
• Potassium-sparing water pills (certain diuretics). Dicloalgan can increase the potassium concentration in the blood.
• Medicines for treating heart failure and high blood pressure (ACE inhibitors and angiotensin II antagonists). Dicloalgan can weaken the effect of these medicines and can also raise the risk for kidney dysfunction.
• Anticoagulant medicines such as warfarin. Like other NSAIDs, Dicloalgan may increase the effect of these medicines.
• Oral antidiabetic medicines. In some cases the dosage of the antidiabetic agents may have to be adjusted. Blood glucose level should be monitored as a precaution.
• Other NSAID medicines (used for pain and inflammation e.g. ibuprofen, COX II inhibitors and aspirin) or medicines containing glucocorticoids. Dicloalgan increases the risk for gastrointestinal ulcers or bleeding.

• Platelet aggregation inhibitors such as acetylsalicylic acid (aspirin) and certain antidepressants

  (selective serotonin reuptake inhibitors or SSRIs). This may increase the risk for gastrointestinal bleeding.

• Ciclosporin and tacrolimus (medicines used to prevent transplant rejections, but also used in the treatment of rheumatic diseases or severe skin diseases). NSAIDs can increase the damaging effect on the kidneys caused by ciclosporin and tacrolimus.
• Methotrexate. Using Dicloalgan within 24 hours before or after methotrexate can increase the concentration of methotrexate in the blood and lead to an increase in the undesirable effects of this substance.
• Medicines for treating gout containing sulphinpyrazone or voriconazole. This can delay the excretion of Dicloalgan, which can result in greater concentration of Dicloalgan in the body and an increase in the undesirable effects of this substance.
• Colestipol and cholestyramine. This can induce a delay or decrease in absorption of Dicloalgan. It is recommended to take Dicloalgan at least one hour before or 4 to 6 hours after the other medicine.
• Quinolones (a type of antibiotic). There have been isolated reports of convulsions.
• Cardiac glycosides: Concommitant use with NSAIDs may exacerbate cardiac failure, reduce renal filtration and increase plasma glycoside levels.
• Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.

Dicloalgan with alcohol

While taking Dicloalgan you should not drink alcohol. Alcohol can increase possible undesirable effects of Dicloalgan, especially tiredness and dizziness and effects on the gastrointestinal system.

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

Do not take <invented name> if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected. You should not take <invented name> during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, <invented name> can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

Breast-feeding

Dicloalgan should not be taken if you are breast-feeding as it might be harmful for your infant. Tell your doctor if you are breast-feeding.

Fertility

Dicloalgan belongs to a group of medicines (NSAIDs) that may affect the fertility of women. This effect is reversible when the medicine is withdrawn.

Therefore the use of Dicloalgan is not recommended for women attempting to conceive, have difficulty conceiving or who are undergoing investigation of infertility.

Driving and using machines

When using Dicloalgan side effects such as visual disturbances, dizziness, drowsiness, feeling very sleepy, or other central nervous system disturbances can occur. This effect is increased in conjunction with alcohol.

If you are affected in this way, you should not drive or operate machinery.

This medicine contains a maximum of 8.02 mg and 10.07 mg sorbitol in each capsule of 12.5 mg and 25 mg strength respectively.

This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.

3. How to take Dicloalgan

Swallow whole capsule with a drink of water.

To ensure the medicine works as well as possible, take the capsule on an empty stomach.

Adults and children aged 14 years and over:

It is important that you use the lowest dose that controls your pain and that you do not take Dicloalgan for longer than necessary.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

For Dicloalgan 12.5 mg

Initially take 1 or 2 soft capsules, then if needed 1 or 2 soft capsules every 4 – 6 hours. In any case, do not take more than 6 soft capsules (75 mg) in 24-hour period.

For Dicloalgan 25 mg

Initially take 1 soft capsule, then if needed 1 soft capsule every 4 – 6 hours. In any case, do not take more than 3 soft capsules (75 mg) in 24-hour period.

Dicloalgan should not be taken for more than 3 days. If symptoms persist or worsen consult your doctor.

If you take more Dicloalgan than you should

If you accidentally take too much, tell your doctor at once or go to the nearest hospital emergency unit immediately, taking the medicine pack with you. You may require medical attention.

If you forget to take Dicloalgan

If you miss a dose, take one as soon as you remember. If it is nearly time for your next dose, skip the missed dose and take the next capsule at the usual time. Do not take a double dose to make up for the one that you missed.

4. Possible side effects

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

Some side effects can be serious.

Stop taking Dicloalgan and tell your doctor at once if you notice:

• severe pain in the upper abdomen, feeling sick, being sick
• vomiting of blood or black particles, black stool or blood in the stool
• allergic reactions such as skin rash, itching, bruising, painful red areas, peeling or blistering
• wheezing or shortness of breath (bronchospasm), difficulty in swallowing, collapse
• swollen face, lips, hands or fingers
• yellowing of your skin or your eyes
• persistent sore throat or high temperature, unusual bleeding or bruising
• an unexpected change in the amount of urine produced and/or its appearance.

• Mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with

  Dicloalgan and followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from the available data).

Tell your doctor immediately if you notice any of the following:

• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome

Medicines such as Dicloalgan may be associated with an increased risk of heart attack (“myocardial infarction”) or stroke.

The side effects listed below have also been reported:

Common (may affect up to 1 in 10 people)

• Headache, dizziness, vertigo
• Nausea, vomiting, diarrhoea, digestive disorders (dyspepsia), abdominal pain, flatulence, loss of appetite
• Skin rash and itching

Uncommon (may affect up to 1 in 100 people)

• Increase in liver enzyme values in the blood

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

• Hypersensitivity, anaphylactic and anaphylactoid reactions (severe allergic reactions including fall in blood pressure and shock)
• Allergic swelling including face oedema (angioneurotic oedema)
• Drowsiness
• Constriction of the airways (asthma) including shortness of breath (dyspnoea)
• Inflammation of the stomach (gastritis), gastric (stomach) or duodenal (intestinal) ulcer (with or without bleeding or perforation)
• Hepatitis (liver inflammation), jaundice
• Hives (urticaria)
• Oedema (fluid retention in the body)

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

• Disorders of red and white blood cell formation
• Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder
• Sensitivity disorders (paraesthesia), memory impairment, fits or spasms, anxiety, tremor, meningitis unrelated to an infection, taste disturbances,
• Visual disturbance, blurred or double vision
• Noises in the ear (tinnitus), hearing impaired
• Palpitations, chest pain, heart muscle weakness (heart failure),
• High blood pressure (hypertension), inflammation of the blood vessels (vasculitis)
• Inflammation of the lungs (pneumonitis),
• Inflammation of the large bowel (colitis), including bleeding and worsening of Crohn's disease or ulcerative colitis, constipation

• Inflammation of the oral mucosa (stomatitis,), inflammation of the tongue, oesophageal lesions

  (damage to the gullet), formation of membrane-like constrictions in the bowel, inflammation of the pancreas (pancreatitis)

• Liver failure
• Skin rash (including eczema and blisters), sensitivity to light, small areas of bleeding in the skin, severe skin reactions such as rash with blister formation (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis / Lyell's syndrome), , loss of hair,

• Acute kidney dysfunction (renal failure), blood in the urine (haematuria), protein in the urine

  (proteinuria), nephrotic syndrome (fluid retention in the body and high levels of protein leaking into the urine), kidney tissue damage (interstitial nephritis, papillary necrosis)

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 Yellow Card Scheme; website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dicloalgan

• 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 carton and blister after “EXP”.

  The expiry date refers to the last day of that month.

• Store below 25°C.
• Store in the original package in order to protect from light and moisture.

6. Contents of the packs and other information

What Dicloalgan contains

The active substance is diclofenac epolamine.

For Dicloalgan 12.5 mg

Each soft capsule contains diclofenac as 15.38 mg diclofenac epolamine equivalent to 12.5 mg diclofenac potassium.

For Dicloalgan 25 mg

Each soft capsule contains diclofenac as 30.76 mg diclofenac epolamine equivalent to 25 mg diclofenac potassium.

The other ingredients are:

Capsule content:

Macrogol 600, glycerol anhydrous, purified water

Capsule shell:

Gelatin, glycerol anhydrous, sorbitol liquid partially dehydrated (E420), hydroxypropylbetadex, sodium hydroxide, purified water.

What Dicloalgan looks like and contents of the pack

For Dicloalgan 12.5 mg

Clear, yellowish coloured, oval gelatin soft capsule with a size of about 0.8 cm containing a slightly viscous solution.

For Dicloalgan 25 mg

Clear, yellowish coloured, oval gelatin soft capsule with a size of about 1 cm containing a slightly viscous solution.

The soft capsules are packed in blisters.

For Dicloalgan 12.5 mg

Pack sizes: 10, 20, 30 or 40 soft capsules.

For Dicloalgan 25 mg

Pack sizes: 10 or 20 soft capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder

IBSA Farmaceutici Italia srl

Via Martiri di Cefalonia, 2

26900 Lodi

Italy

Manufacturer

IBSA Farmaceutici Italia srl

Via Martiri di Cefalonia, 2

26900 Lodi

Italy

This leaflet was last revised in XX/2022.