Diclovit

Leaflet included in the packaging: patient information

Diclovit, 50 mg+50 mg +50 mg+0.25 mg, hard capsules
Diclofenac sodium + Thiamine hydrochloride(Vitamin B1) + Pyridoxine hydrochloride(Vitamin B6) + Cyanocobalamin(Vitamin B12)

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Diclovit and what is it used for
• 2. Important information before taking Diclovit
• 3. How to take Diclovit
• 4. Possible side effects
• 5. How to store Diclovit
• 6. Contents of the packaging and other information

1. What is Diclovit and what is it used for

Diclovit contains a combination of active substances - diclofenac sodium and vitamins B1, B6, and B12.
Diclofenac belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
Diclofenac has analgesic, anti-inflammatory, and antipyretic effects.
Like all vitamins, the vitamins in this medicine are essential dietary components that cannot be produced by the body itself.
In the treatment of nervous system disorders, vitamins B1, B6, and B12 work by supplementing vitamin B1 deficiencies.
Diclovit is used in adults and adolescents from 18 years of age to treat:

• pain in inflammatory conditions not related to rheumatoid arthritis
• rheumatoid arthritis
• symptoms of degenerative joint and spine diseases
• neuralgia, e.g., in the neck or arm area, lumbago, sciatica

2. Important information before taking Diclovit

When not to take Diclovit

• if the patient is allergic to diclofenac, thiamine (Vitamin B1), pyridoxine (Vitamin B6), or cyanocobalamin (Vitamin B12) or any of the other ingredients of this medicine (listed in section 6);
• if the patient has had an asthma attack, sudden rhinitis, rash, or chest pain after taking acetylsalicylic acid or other painkillers or

if the patient has asthma, and these medicines cause or worsen breathing difficulties;

• if the patient has stomach or duodenal ulcer disease, gastrointestinal bleeding, or perforation;
• if the patient has had recurrent stomach ulcers or bleeding (two or more cases of stomach ulcers or gastrointestinal ulcers in the past);
• if the patient has had gastrointestinal bleeding or perforation after taking NSAIDs;
• in case of blood disorders (blood formation disorders, bone marrow damage, disorders of red blood cell formation, increased tendency to bleeding, or blood clotting disorders);
• if the patient has or has had circulatory disorders (peripheral vascular disease);
• if the patient has had a brain hemorrhage;
• if the patient is currently experiencing severe bleeding;
• in case of severe liver or kidney disorders;
• in women in the last three months of pregnancy (see section 2. Pregnancy, breastfeeding, and fertility);
• if the patient has been diagnosed with heart disease and/or cerebrovascular disease, e.g., after a heart attack, stroke, transient ischemic attack (mini-stroke), or vascular surgery or angioplasty;
• in children and adolescents under 18 years of age.

Warnings and precautions

Before starting treatment with Diclovit, the patient should discuss the following with their doctor:

• if the patient is a smoker,
• if the patient has diabetes,
• if the patient has chest pain (angina pectoris), thrombosis, high blood pressure, or elevated cholesterol or triglyceride levels.

Special caution is required in the following cases:

• if the patient is in the first six months of pregnancy or is breastfeeding (see section 2. Pregnancy, breastfeeding, and fertility). Diclovit is not recommended during the first 6 months of pregnancy and during breastfeeding. In the last three months of pregnancy, this medicine should not be taken.
• if the patient has porphyria (a disorder of red blood cell production): Diclovit should be taken with caution, as it may exacerbate the disease.
• in elderly patients (over 65 years of age): the doctor should prescribe the smallest possible dose for the shortest possible period, as the risk of side effects increases with the size of the dose and duration of treatment, and side effects can be more severe in these patients (see section 3).
• if the patient has had gastrointestinal disorders: when taking all NSAIDs, gastrointestinal bleeding, ulcers, and perforation have been reported, sometimes fatal. These events can occur at any time during treatment, with or without warning signs or a history of serious gastrointestinal events.

The risk of gastrointestinal bleeding, ulcers, or perforation increases with the dose of NSAIDs in patients with a history of ulcers, especially if complications such as bleeding or perforation have occurred (see section 2. "When not to take Diclovit") and in elderly patients. In such patients, treatment should be started with the lowest available dose. The doctor may also recommend additional treatment with a medicine that protects the stomach lining.

This is also recommended if the patient is already taking low doses of acetylsalicylic acid.

If the patient has had side effects affecting the gastrointestinal tract in the past, especially in elderly patients, they should inform their doctor if they experience any unusual symptoms (especially bleeding), mainly in the initial phase of treatment.

Special caution is required if the patient is taking medicines that can increase the risk of ulcers or bleeding, such as steroids, anticoagulants, or certain antidepressants (so-called SSRIs - selective serotonin reuptake inhibitors) (see also section 2. "Diclovit and other medicines").

If gastrointestinal bleeding or ulcers occur during treatment with Diclovit, the medicine should be discontinued immediately.

The medicine should be used with caution in patients with inflammatory bowel disease (ulcerative colitis, Crohn's disease), as their condition may worsen (see section 4).

• if the patient has liver function disorders: taking this medicine may worsen liver function. The patient should inform their doctor about any current or past liver disease. The doctor may recommend regular monitoring tests.
• rarely, liver inflammation has been reported. The patient should pay attention to all signs of liver disorders, such as general deterioration, fatigue, loss of appetite, and immediately inform their doctor.
• if the patient has kidney or heart disorders, high blood pressure, or swelling.
• if the patient is to undergo surgery: if the patient is taking diclofenac, they should consult their doctor before any surgical or dental procedure. Diclovit may temporarily inhibit platelet aggregation and thus inhibit blood clotting. After major surgery, Diclovit should only be used under close medical supervision.
• if the patient has heart disorders, narrowed blood vessels, diabetes, brain disorders, or elevated lipid levels ("cholesterol"), or if the patient smokes. Taking Diclovit is associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke.
• if the patient experiences skin symptoms while taking Diclovit: very rarely, during treatment with NSAIDs like diclofenac, severe skin reactions with blistering and peeling have been reported, most often in the first month of treatment.
• if the patient has systemic lupus erythematosus or mixed connective tissue disease (immune system disorders):

In patients with these diseases, NSAIDs like diclofenac have very rarely caused symptoms of meningitis (stiff neck, headache, nausea, vomiting, fever, and changes in consciousness).

• if the patient has epilepsy, Parkinson's disease, or severe mental disorders. If unusual sensations occur in the hands or feet (possible symptoms of nerve damage called peripheral neuropathy), Diclovit should be discontinued immediately.

General recommendations
Patients should avoid taking Diclovit with other NSAIDs (including so-called COX-2 inhibitors).
Side effects can be minimized by taking the smallest effective dose for the shortest possible time.
Allergic reactions
If the patient experiences the first signs of an allergic reaction, such as facial swelling, respiratory tract swelling (e.g., throat swelling), difficulty breathing, asthma attack, chest pain, rapid heartbeat, skin reactions (e.g., hives, redness, rash, urticaria), and/or a drop in blood pressure, they should discontinue Diclovit and immediately consult a doctor.

In patients with asthma, allergic rhinitis (e.g., hay fever), nasal polyps, or certain chronic respiratory disorders associated with breathing difficulties, allergic reactions to NSAIDs have been observed more frequently than in other patients; however, these reactions can also occur in people who have not previously experienced allergic reactions.

Treatment of pain and associated diseases
If the patient's general condition does not improve after taking Diclovit or if pain, fever, fatigue, or other symptoms persist, they should consult their doctor.

Painkillers can mask the signs of another disease by relieving pain and reducing inflammation.

The patient may need additional treatment besides pain relief.

Medication-induced headaches
If a painkiller is taken for a long time, it can cause headaches that should not be treated by increasing the dose.

The patient should consult their doctor if they experience frequent headaches while taking Diclovit.

Kidney damage caused by painkillers
Regular long-term use of certain painkillers can lead to permanent kidney damage and an increased risk of kidney failure.

If any of the above conditions apply to the patient or have applied in the past, they should discuss this with their doctor.

Laboratory tests
The doctor may recommend tests, including blood morphology, blood clotting, kidney function, and liver function.

In case of long-term intake of vitamin B6 doses exceeding 50 mg per day or short-term intake of doses exceeding 1 g, a feeling of tingling or numbness in the hands or feet (symptoms of peripheral neuropathy or paresthesia) has been observed.

If the patient experiences tingling or numbness, they should consult their doctor, who will determine the dosage and, if necessary, recommend discontinuing the medicine.

Diclovit with food, drink, and alcohol

Consuming alcohol during treatment with diclofenac increases the risk of gastrointestinal bleeding and should therefore be avoided.

Vitamin B6 absorption is reduced by alcohol and tea.

If vitamin B6 is taken with beverages containing sulfates (e.g., wine), it may break down too quickly and lose its effectiveness.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.

Pregnancy
The amount of vitamins B1, B6, and B12 in Diclovit exceeds the daily requirement for these vitamins during pregnancy; therefore, Diclovit should not be taken during pregnancy.

Diclovit should not be taken if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery.

Diclovit may cause kidney and heart disorders in the unborn child.

It may also increase the risk of bleeding in the patient and the child and cause prolongation or delay of labor.

In the first six months of pregnancy, Diclovit should not be taken unless the doctor considers it absolutely necessary.

If treatment is necessary during this period or during attempts to conceive, the smallest possible dose should be used for the shortest possible time.

From the 20th week of pregnancy, Diclovit may cause kidney disorders in the unborn child if taken for more than a few days.

This can lead to a low level of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart.

If treatment is required for a longer period, the doctor may recommend additional monitoring.

Breastfeeding
Small amounts of the active substance diclofenac pass into breast milk.

Although a negative effect on the child is not known, breastfeeding should be temporarily discontinued during short-term use of this substance.

If long-term use of diclofenac or high doses are necessary, breastfeeding should be discontinued.

Vitamins B1, B6, and B12 pass into human milk.

High doses of vitamin B6 may reduce milk production.

Therefore, Diclovit should not be taken during breastfeeding.

Fertility
Like other NSAIDs, diclofenac may affect female fertility and is not recommended for women planning to conceive.

Women who have difficulty conceiving or are undergoing fertility tests should consider discontinuing diclofenac.

Driving and operating machinery

This medicine may slow down reaction time and the ability to drive vehicles.
If the patient experiences side effects such as vision disturbances, dizziness, or increased fatigue, they should avoid activities that require increased concentration (e.g., driving vehicles, operating machinery).

Diclovit contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is considered "sodium-free".

3. How to take Diclovit

This medicine should always be taken according to the doctor's recommendations.

In case of doubts, the patient should consult their doctor or pharmacist.

The dose of Diclovit will depend on the type and severity of the disease, so the patient should carefully follow the doctor's recommendations.

If the doctor does not recommend otherwise, the dose should be as small as possible, and the treatment period as short as possible.

The total daily dose is usually divided into two or three single doses.

Recommended dose:

Adults and adolescents from 18 years of age

The maximum dose should not exceed 3 capsules per day (150 mg of diclofenac sodium).

At the start of treatment, a dose of 2 to 3 capsules per day is recommended.

In milder cases or during longer treatment, a dose of 1 to 2 capsules per day is usually sufficient.

Patients with kidney function disorders

Diclofenac should not be taken by patients with severe kidney failure (see section 2).

Patients with liver function disorders

Diclofenac should not be taken by patients with severe liver failure (see section 2).

Patients over 65 years of age

In elderly patients, special caution is required due to the possibility of other diseases or malnutrition.

In particular, the smallest possible dose is recommended for elderly patients and patients with malnutrition (see section 2).

Use in children and adolescents

Due to the high content of vitamin B, Diclovit should not be taken by children and adolescents under 18 years of age.

Method of administration

The medicine is intended for oral administration.

The capsules should be swallowed whole before meals, without chewing, with a sufficient amount of water.

Overdose

In case of overdose, the patient should consult their doctor or go to the hospital.

Symptoms of overdose may include disorders of the nervous system, such as headache, dizziness, drowsiness, loss of consciousness, and seizures.

Additionally, tinnitus, abdominal pain, nausea, and vomiting may occur, as well as gastrointestinal bleeding, liver or kidney function disorders, a drop in blood pressure, breathing difficulties, or cyanosis (blue discoloration of the skin due to low oxygen levels in the blood).

If overdose is suspected, the patient should immediately consult their doctor, who will decide on the course of action depending on the severity of the poisoning.

Missed dose

The patient should not take a double dose to make up for a missed dose.

The patient should take the dose as soon as possible or, if the next dose is approaching, take it according to the recommendations.

In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

The occurrence of side effects can be reduced by taking the smallest effective dose for the shortest possible time.

The most common side effects are related to the gastrointestinal system.

Ulcers, perforation, or gastrointestinal bleeding have been reported, sometimes fatal, especially in elderly patients.

After taking NSAIDs, nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, and black stools (indicating gastrointestinal bleeding) have been reported, as well as gastrointestinal ulcers (with or without bleeding or perforation) and inflammatory bowel disease (see also section 2. "Warnings and precautions").

Rarely, esophagitis (inflammation of the esophagus) has been reported.

In connection with NSAID treatment, edema (fluid accumulation), high blood pressure, and heart failure have been reported.

Taking medicines like Diclovit is associated with an increased risk of heart attack or stroke.

Unusual sensations in the hands and feet (possible symptoms of peripheral neuropathy) have been reported after long-term use (more than 6 to 12 months) of high doses of vitamin B6 (more than 50 mg per day).

If the following symptoms occur, the patient should discontinue Diclovit and immediately consult their doctor:

• abdominal or stomach pain, heartburn
• bloody vomiting, black or bloody stools, blood in urine
• skin reactions such as rash or hives
• breathing difficulties, shortness of breath, swelling in the face or neck
• jaundice of the eyes or skin
• severe fatigue or loss of appetite
• prolonged sore throat, mouth ulcers, increased fatigue, or fever
• nosebleeds, skin bleeding
• facial swelling, swelling of the feet or ankles
• reduced urine output with increased fatigue
• severe headache or stiff neck
• chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome
• changes in consciousness

After short-term or long-term use, the following side effects may occur:

• Very common(occurring in more than 1 in 10 patients)
• Nausea, vomiting, diarrhea
• Common(occurring in less than 1 in 10 patients)
• Allergic skin reactions (rash, hives)
• Headache, dizziness, agitation, or drowsiness
• Indigestion, abdominal pain, bloating, loss of appetite
• Liver function disorders (increased activity of certain liver enzymes)
• Rash
• Uncommon(occurring in less than 1 in 100 patients)
• Fluid accumulation in certain parts of the body (edema), especially in patients with high blood pressure or kidney function disorders
• Rare(occurring in less than 1 in 1,000 patients)
• Asthma (including breathing difficulties)
• Stomach inflammation, bloody vomiting, gastrointestinal bleeding, black stools (indicating gastrointestinal bleeding), stomach ulcers (with or without bleeding or perforation)
• Acute liver inflammation with or without jaundice, liver damage
• Hives
• Very rare(occurring in less than 1 in 10,000 patients)
• During NSAID treatment, worsening of infections has been reported
• Anemia due to red blood cell destruction, blood formation disorders with a decrease in the number of certain or all blood cells (platelets, red and/or white blood cells)
• Severe allergic reactions with facial swelling, tongue, and/or respiratory tract swelling with accompanying breathing difficulties, rapid heartbeat, drop in blood pressure, and anaphylactic shock
• Disorders of sensation and taste, memory disorders, confusion, seizures, meningitis (symptoms: stiff neck, headache, nausea, vomiting, fever, and changes in consciousness), irritability
• Abnormal changes in perception and thinking, depression, anxiety, nightmares
• Visual disturbances (blurred vision, double vision)
• Transient hearing disturbances, tinnitus
• Heart failure, myocardial infarction, palpitations
• High blood pressure, allergic blood vessel inflammation
• Allergic lung inflammation
• Ulcerative esophagitis, stomach inflammation, and damage to the mucous membrane in the mouth and esophagus, laryngitis, intestinal spasm (after taking tablets), pancreatitis
• Sudden severe liver inflammation leading to liver failure (even without warning signs)
• Rash, redness, increased sensitivity to light, skin bleeding, severe skin reactions with blistering and peeling (skin blistering reactions, Lyell's syndrome), hair loss, allergic skin reactions (Stevens-Johnson syndrome), hives
• Acute kidney failure, abnormal urine test results, such as blood or protein in the urine (hematuria, proteinuria), kidney inflammation, kidney function disorders
• Frequency not known(frequency cannot be estimated from available data)
• Long-term use of vitamin B6 doses exceeding 50 mg per day (more than 6 to 12 months) may lead to peripheral neuropathy (nerve damage causing tingling or numbness).

Reporting side effects

If the patient experiences any side effects, including any side effects not mentioned in this leaflet, they should inform their doctor or pharmacist.

Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Diclovit

The medicine should be stored out of sight and reach of children.

Store in a temperature below 25°C, in the original packaging.

Do not use this medicine after the expiry date stated on the packaging.

Medicines should not be disposed of via wastewater or household waste.

The patient should ask their pharmacist how to dispose of medicines that are no longer needed.

This will help protect the environment.

6. Contents of the packaging and other information

What Diclovit contains

• The active substances of Diclovit are diclofenac sodium, thiamine hydrochloride (Vitamin B1), pyridoxine hydrochloride (Vitamin B6), and cyanocobalamin (Vitamin B12).
• One capsule contains 50 mg of diclofenac sodium, 50 mg of thiamine hydrochloride (Vitamin B1), 50 mg of pyridoxine hydrochloride (Vitamin B6), and 0.25 mg of cyanocobalamin (Vitamin B12).
• The other ingredients are povidone, methacrylic acid, and ethyl acrylate copolymer (1:1), dispersion 30%, triethyl citrate, talc, red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), and gelatin.

What Diclovit looks like and contents of the pack

Hard capsules with a ivory-colored body and an orange cap.

Package sizes: 30 and 50 capsules.

Marketing authorization holder and manufacturer

G.L. Pharma GmbH
Schlossplatz 1, 8502 Lannach
Austria

For more detailed information, please contact the representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Phone: 022 636 52 23; 022 636 53 02
[email protected]

Date of last revision of the leaflet: