Diclofenac Doc Generici

Package leaflet: Information for the patient

DICLOFENAC DOC 75 mg/3 ml solution for injection for intramuscular use

Generic medicine
Please read all of this leaflet carefully before you use this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What DICLOFENAC DOC is and what it is used for
2. What you need to know before using DICLOFENAC DOC
3. How to use DICLOFENAC DOC
4. Possible side effects
5. How to store DICLOFENAC DOC
6. Contents of the pack and other information

1. What DICLOFENAC DOC is and what it is used for

DICLOFENAC DOC contains the active substance diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) that work by reducing inflammation and pain.
This medicine is indicated for the treatment of:

• severe pain caused by inflammation of the musculoskeletal system;
• severe pain caused by spasms of the smooth muscles of internal organs (e.g. the intestine).

2. What you should know before using DICLOFENAC DOC

Do not use DICLOFENAC DOC

• if you are allergic to sodium diclofenac, aspirin, ibuprofen, or any other NSAID, or to any of the components of DICLOFENAC DOC (listed in section 6). Signs of hypersensitivity reactions include swelling of the face and mouth (angioedema), breathing difficulties, chest pain, runny nose, skin rash, or any other allergic-type reaction;
• if you have stomach or intestinal lesions (ulcers), bleeding, or perforation;
• if you have previously experienced stomach or intestinal bleeding or perforation due to treatment with NSAIDs, or if you have had recurrent peptic ulcer/bleeding (two or more distinct episodes of confirmed ulceration or bleeding);
• if you are in the last trimester of pregnancy or are breastfeeding (see section “Pregnancy, breastfeeding and fertility”);
• if you have severe liver, kidney, or heart disease;
• if you suffer from heart problems or impaired blood circulation to the brain (established cardiopathy and/or cerebrovascular disease), for example, if you have had a heart attack, stroke, mini-stroke (TIA), or obstruction of blood vessels supplying the heart or brain, or undergone surgery to remove or prevent such obstructions;
• if you suffer or have suffered from circulatory problems (peripheral arterial disease);
• if you previously experienced an allergic reaction such as asthma, nasal inflammation, or skin irritation after taking anti-inflammatory medicines containing acetylsalicylic acid or other pain or anti-inflammatory medicines belonging to the NSAID group;
• if you have severe stomach problems;
• if you are taking high doses of medicines that promote urine elimination (diuretics);
• if you have ongoing bleeding (haemorrhage) or are predisposed to developing bleeding;
• if you have a disorder affecting blood cell production;
• if you are taking medicines used to improve blood circulation (anticoagulants);
• if you are under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using DICLOFENAC DOC.
Inform your doctor and use this medicine with caution in the following cases:

• if you are elderly or debilitated; in this case, the lowest effective dose should be used to avoid an increased frequency of adverse effects, especially stomach bleeding and perforation, which may be fatal;
• if you have any stomach or intestinal problems such as lesions (ulcers), ulcerative colitis, or Crohn’s disease; in these cases, accurate diagnosis and close medical supervision during treatment are necessary;
• if you have heart problems (congestive heart failure, high blood pressure (hypertension), or are at high risk of developing them (elevated blood lipid levels (hyperlipidemia), diabetes, smoking), as this medicine may cause fluid retention and swelling due to fluid accumulation (edema); in such cases, the lowest effective dose for the shortest possible duration is recommended;
• if you have liver problems or a liver disease called hepatic porphyria; in these cases, accurate diagnosis and close medical supervision during treatment are required, with periodic monitoring of liver enzymes. If liver function abnormalities persist, treatment should be discontinued;
• if you have kidney problems, as this medicine may cause fluid retention and swelling due to fluid accumulation (edema);
• if you suffer from asthma, seasonal allergic rhinitis, nasal mucosa swelling (nasal polyps), obstructive lung diseases, or chronic respiratory tract infections, or other allergic reactions such as skin reactions, itching, or urticaria. In these cases, symptoms may worsen with breathing difficulties (bronchospasm) or severe allergic reactions including anaphylactic shock;
• if you have blood disorders; in this case, platelet aggregation should be closely monitored, as coagulation problems may occur, especially with prolonged treatment;
• if you have ever developed severe skin rash or skin peeling, rash with blisters and/or mouth ulcers after taking DICLOFENAC DOC or other analgesics.

Inform your doctor if you experience any of the following symptoms during treatment:

• stomach or intestinal bleeding, ulceration, or perforation, which may be fatal. In this case, discontinue treatment. Caution is advised in people taking other medicines that may increase the risk of ulceration or bleeding, such as acetylsalicylic acid, systemic corticosteroids (acting away from the site of administration), anticoagulants, antiplatelet agents, or selective serotonin reuptake inhibitors (antidepressants) (see section “Other medicines and DICLOFENAC DOC”). In these cases, taking a stomach-protective agent (proton pump inhibitors or misoprostol) may be beneficial. To reduce risk, treatment should be initiated and maintained at the lowest effective dose;
• if you develop severe skin reactions (exfoliative dermatitis, Stevens-Johnson syndrome, or toxic epidermal necrolysis). These reactions usually occur within the first month of treatment. Discontinue treatment at the first sign of skin rash, mucosal lesions, or any other reaction.

This medicine may increase the risk of heart attack or stroke, especially when high doses are used or treatment is prolonged. Do not exceed the recommended dose or duration of treatment.
Like other anti-inflammatory medicines, DICLOFENAC DOC may reduce the signs and symptoms of infection.
Avoid using this medicine with other systemic NSAIDs.
Before taking diclofenac, ensure your doctor is aware:

• if you have heart problems, history of stroke, or think you may be at risk for these conditions;
• if you smoke;
• if you have diabetes;
• if you suffer from chest pain due to heart problems (angina), blood clots, high blood pressure, high cholesterol or triglyceride levels.

Inform your doctor if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract before receiving/taking/using DICLOFENAC DOC, as DICLOFENAC DOC may sometimes impair wound healing in the intestine following surgery.
Adverse effects can be minimized by using the lowest effective dose for the shortest necessary duration.
This medicine must be used under strict medical supervision. After two days of treatment, it is advisable to switch to oral therapy. Use of vials for treatment longer than two days should only be performed in hospitals or healthcare facilities.

Children and adolescents
DICLOFENAC DOC is not recommended in children under 14 years of age due to lack of safety and efficacy data for this medicine.

Other medicines and DICLOFENAC DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Diclofenac may affect or be affected by other medicines containing the following active substances:

• lithium, a medicine used for psychiatric disorders;
• digoxin, a medicine used to treat heart conditions;
• medicines used to lower high blood pressure such as diuretics, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin II antagonists;
• other anti-inflammatory medicines (both NSAIDs and corticosteroids);
• anticoagulant and antiplatelet medicines used to improve blood circulation such as warfarin;
• medicines used for depression such as selective serotonin reuptake inhibitors (SSRIs);
• medicines used for diabetes;
• methotrexate, a medicine used for psoriasis, rheumatism, and certain cancers;
• cyclosporine, a medicine used after organ transplants;
• quinolone antibiotics, used to treat infections;
• phenytoin, a medicine used for epilepsy;
• colestipol and cholestyramine, medicines used to reduce intestinal fat absorption;
• sulfinpyrazone, voriconazole, or other medicines that inhibit diclofenac metabolism, as they may increase the medicine’s effects.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not take DICLOFENAC DOC during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your or your baby’s tendency to bleed and may delay or prolong labour more than expected.
You should not take DICLOFENAC DOC during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. From week 20 of pregnancy, DICLOFENAC DOC may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or cause narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
Do not use this medicine if you are breastfeeding, as diclofenac passes into breast milk.
Diclofenac may affect female fertility and is not recommended for women trying to conceive. Discontinue use of this medicine if you experience difficulty conceiving or are undergoing fertility investigations.

Driving and using machines
This medicine may cause visual disturbances, dizziness, vertigo, or drowsiness. Avoid driving or operating machinery if you experience these symptoms.

DICLOFENAC DOC contains sodium metabisulfite, benzyl alcohol, propylene glycol, and sodium

• This medicine contains sodium metabisulfite, which may rarely cause severe hypersensitivity reactions and bronchospasm.
• This medicine contains 120 mg of benzyl alcohol per vial.
  • Benzyl alcohol may cause allergic reactions.
  • Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems (gasping syndrome), in young children. This medicine is not indicated for use in children.
  • Consult your doctor or pharmacist if you are pregnant or breastfeeding. Large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
  • Consult your doctor or pharmacist if you have liver or kidney disease. Large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
• This medicine contains 600 mg of propylene glycol per vial. It may cause symptoms similar to those caused by alcohol.
• This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., it is essentially “sodium-free”.

3. How to use DICLOFENAC DOC

Use this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
The recommended dose in adults is 1 vial per day, injected deeply into the muscle (intramuscular route) in the upper outer quadrant of the buttock.
In more severe cases (e.g. colic), 2 vials per day may be administered (one in each buttock), several hours apart; alternatively, one vial of injectable diclofenac may be combined with other pharmaceutical forms (tablets, suppositories) up to a maximum daily dose of 150 mg of diclofenac.
This medicine must not be administered for more than two consecutive days; if further treatment is needed, it can be continued with diclofenac tablets or suppositories.
Use in the elderly
If you are elderly, your doctor may reduce the dose compared to that recommended for adults.
If you use more DICLOFENAC DOC than you should
Overdose may cause symptoms such as vomiting, gastrointestinal bleeding, diarrhoea, dizziness, ringing in the ears (tinnitus), or seizures; in more severe cases, serious kidney problems (acute renal failure) and liver damage may occur.
If you have taken an excessive dose of DICLOFENAC DOC, contact your doctor immediately or go to the nearest hospital.
If you forget to use DICLOFENAC DOC
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects may be serious.
Stop taking DICLOFENAC DOC and contact your doctor immediately if you notice any of the following serious side effects. You may require urgent medical treatment:

• A severe skin allergic reaction which may include large red and/or dark widespread patches, swelling of the skin, blisters, and itching (Fixed generalized bullous eruption due to drugs).
• Serious gastrointestinal disorders, particularly stomach or intestinal pain or bleeding.
• Dark stools.
• Mild abdominal cramps and tenderness occurring shortly after starting treatment with DICLOFENAC DOC, followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from available data).
• Chest pain, which may indicate a potentially serious allergic reaction called Kounis syndrome.
• Reactions at the injection site, including pain, redness, swelling, hard nodule, ulcers, and bruising. These reactions may worsen with darkening and death of the skin and underlying tissues surrounding the injection site, eventually healing with scarring; this condition is known as Nicolau syndrome.

The following side effects may occur:
Common (may affect up to 1 in 10 people)

• Headache and dizziness;
• Vertigo;
• Nausea, vomiting, diarrhoea, indigestion (dyspepsia), abdominal pain, flatulence, decreased appetite (anorexia);
• Liver function disorders (increased transaminases);
• Skin rash;
• Reaction, pain, and hardening at the injection site.

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

• Hypersensitivity, allergic reactions including severe anaphylactic and anaphylactoid reactions (including hypotension and shock);
• Drowsiness;
• Asthma and breathing difficulties (dyspnoea);
• Stomach disorders such as gastritis, gastrointestinal bleeding, blood in vomit (haematemesis), blood in stools (haemorrhagic diarrhoea, melena), gastrointestinal ulcer (with or without bleeding or perforation);
• Liver problems such as hepatitis and yellowing of the skin and whites of the eyes (jaundice);
• Skin irritation (urticaria);
• Swelling due to fluid accumulation (oedema);
• Damage and death of tissues surrounding the injection site (injection site necrosis).

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

• Decrease in blood platelets (thrombocytopenia);
• Decrease in white blood cells (leucopenia, agranulocytosis);
• Decrease in red blood cells (anaemia, including haemolytic and aplastic anaemia);
• Swelling of the skin and mucous membranes, particularly affecting the face (angioneurotic oedema);
• Confusion, depression, insomnia, nightmares, irritability, psychotic reactions;
• Altered sensation in limbs (paraesthesiae), tremors;
• Memory impairment, seizures, anxiety, inflammation of the brain (aseptic meningitis), taste disturbances, cerebrovascular events;
• Visual disturbances, blurred vision, double vision (diplopia);
• Ringing in the ears (tinnitus), worsening of hearing;
• Increased awareness of heartbeats (palpitations);
• Chest pain, heart failure, heart attack;
• Increased blood pressure (hypertension);
• Inflammation of blood vessels (vasculitis);
• Lung inflammation (pneumonitis);
• Intestinal inflammation (colitis), including haemorrhagic colitis and worsening of ulcerative colitis or Crohn’s disease;
• Constipation, intestinal blockage (diaphragm-like intestinal stenosis);
• Inflammation of the mouth (stomatitis, including ulcerative stomatitis), tongue (glossitis), oesophageal disorders, inflammation of the pancreas (pancreatitis);
• Severe liver problems (fulminant hepatitis, liver necrosis, liver failure);
• Inflammation of the skin and mucous membranes such as blistering rashes, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), exfoliative dermatitis;
• Hair loss;
• Sensitivity to light (photosensitivity);
• Skin redness with bleeding (purpura, allergic purpura);
• Itching;
• Kidney problems such as acute renal failure, nephrotic syndrome, interstitial nephritis, renal papillary necrosis;
• Presence of blood or protein in urine (haematuria, proteinuria);
• Inflammation at the injection site with pus formation (abscess).

Frequency not known (frequency cannot be estimated from the available data)

• A skin allergic reaction, which may include round or oval patches with redness and swelling of the skin, skin rash with blisters, and itching (Drug-induced fixed eruption). Darkening of the skin in the affected areas may also occur, which could persist after healing. A drug-induced fixed eruption usually recurs in the same site (or sites) if the medicine is taken again.
• Tissue damage at the injection site.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DICLOFENAC DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Exp”.
The expiry date refers to the last day of that month.
Store below 25 °C. Keep in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What DICLOFENAC DOC contains

• The active substance is sodium diclofenac. Each vial contains 75 mg of sodium diclofenac.
• The other components are: mannitol, sodium metabisulfite, benzyl alcohol, propylene glycol, sodium hydroxide, water for injections.

Description of the appearance of DICLOFENAC DOC and package contents
Injectable solution for intramuscular use, in a pack containing 5 vials of clear glass, each containing 75 mg/3 ml.
Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan - Italy.
Manufacturer
Esseti Farmaceutici S.r.l. - Via Campobello 15 - 00071 Pomezia (Rome) - Italy.