Almiral 75 mg. 3 ml. 5 ampules

1. What ALMIRAL is and what it is used for
Your medicine is called ALMIRAL and comes as an ampoule containing a solution for injection. Each ampoule contains 75 mg of the active substance diclofenac sodium.

ALMIRAL belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to treat pain and inflammation.

What ALMIRAL is used for
ALMIRAL intramuscular injections are used to treat the following conditions:

Sudden rheumatic or degenerative joint pain (arthritis), back pain, "frozen shoulder" syndrome, "tennis elbow," and other forms of rheumatism
Gout attacks
Pain associated with gallstones and kidney stones
Pain and swelling following surgery or injury
Severe migraine attacks.
ALMIRAL intravenous infusions are used to treat or prevent pain after surgery.

How ALMIRAL works
ALMIRAL relieves symptoms of inflammation, such as pain and swelling, by blocking the production of molecules (prostaglandins) that cause inflammation, pain, and fever. It does not treat the underlying causes of the inflammation or fever.

If you have any questions about how ALMIRAL works or why this medicine has been prescribed for you, please consult your doctor. Monitoring during treatment with ALMIRAL
If you have established heart disease or significant risk factors for heart disease, your doctor will periodically assess whether you should continue treatment with ALMIRAL, especially if your treatment lasts longer than 4 weeks.

If you have liver or kidney impairment or a blood disorder, you will undergo blood tests during treatment. These will monitor your liver function (transaminase levels), kidney function (creatinine levels), or blood cell counts (white and red blood cells and platelets). Based on these blood tests, your doctor will decide whether to stop treatment with ALMIRAL or adjust the dose.

2. What you need to know before you use ALMIRAL
Follow all your doctor's instructions carefully, even if they differ from the general information in this leaflet.

Do not use ALMIRAL:
if you are allergic to diclofenac, sodium bisulfite, or any of the other ingredients of this medicine (listed in section 6).
if you have ever had allergic reactions when taking medicines for inflammation or pain (such as acetylsalicylic acid/aspirin, diclofenac, or ibuprofen). Reactions may include asthma, chest pain, runny nose, skin rash, or swelling of the face, lips, tongue, throat, and/or limbs (signs of angioedema). Consult your doctor if you think you might be allergic
if you have a stomach or duodenal ulcer
if you have gastrointestinal bleeding or perforation (symptoms may include blood in the stool or black stools)
if you suffer from kidney or liver impairment
if you suffer from severe heart disease
if you are in the last three months of pregnancy
if you have established heart disease and/or cerebrovascular disease—for example, 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 these blockages;
if you have or have had blood circulation problems (peripheral arterial disease).
Make sure your doctor is informed before you take diclofenac

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 minimized by using the lowest effective dose for the shortest duration necessary.

Inform your doctor if you have recently undergone or are about to undergo stomach or intestinal surgery before using ALMIRAL, as ALMIRAL can sometimes impair intestinal wound healing following surgery.

If you have any of the listed conditions, tell your doctor and do not take ALMIRAL. If you think you might be allergic, consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before using ALMIRAL.
Take special care with ALMIRAL:
if you have established heart or blood vessel disease (also known as cardiovascular disease, including uncontrolled high blood pressure, congestive heart failure, established ischaemic heart disease, or peripheral arterial disease), as treatment with ALMIRAL is generally not recommended in these cases
if necessary, patients with established cardiovascular disease, uncontrolled hypertension, or significant risk factors for heart disease may be treated with ALMIRAL only after careful assessment and only at doses < 100 mg daily, when initial treatment with ALMIRAL solution for injection is continued with ALMIRAL tablets for more than 4 weeks
It is important to take the lowest dose of ALMIRAL that relieves your pain and/or swelling for the shortest possible time, in order to keep the risk of cardiovascular side effects as low as possible
if you are taking ALMIRAL at the same time as other anti-inflammatory medicines, including acetylsalicylic acid, corticosteroids, anticoagulants, or selective serotonin reuptake inhibitors (SSRIs) (see "Other medicines and ALMIRAL")
if you suffer from asthma or hay fever (seasonal allergic rhinitis)
if you have or have ever had gastrointestinal problems such as a stomach ulcer, bleeding, or black ...stools, stomach discomfort, or heartburn after taking non-steroidal anti-inflammatory drugs
if you have inflammation of the large intestine (ulcerative colitis) or the small intestine (Crohn's disease)
if you have kidney or liver disease
if you are dehydrated (due to illness, diarrhea, or before or after surgery)
if you have swollen legs
if you have an increased tendency to bleed or another blood disorder, including a rare liver condition called porphyria
if you have ever experienced a severe skin rash, skin peeling, blistering, and/or mouth sores after using ALMIRAL or other painkillers.
If you have any of the conditions listed above, inform your doctor before you start using ALMIRAL solution for injection.

If, at any time during treatment with ALMIRAL, you experience signs or symptoms of heart or blood vessel problems—such as chest pain, shortness of breath, weakness, or slurred speech—contact your doctor immediately.
ALMIRAL may mask the symptoms of an infection (such as headache or fever), making it difficult to detect and treat. If you feel unwell and need to see a doctor, be sure to tell them that you are taking ALMIRAL.
In very rare cases, patients taking ALMIRAL—as well as other anti-inflammatory drugs—may experience serious allergic skin reactions (such as a rash). Reactions at the injection site have been reported following intramuscular administration (a technique for injecting the medication deep into the muscle) of ALMIRAL, including injection site pain, redness, swelling/hardening, ulceration, and occasionally bruising or pus accumulation, as well as damage to the skin and subcutaneous tissue (especially following incorrect administration into fatty tissue)—a condition known as Nicolau syndrome.

If you experience any of the listed symptoms, inform your doctor immediately.

Other medicines and ALMIRAL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. It is particularly important to tell your doctor if you have been taking any of the following medicines:

lithium or selective serotonin reuptake inhibitors (SSRIs) – medicines used to treat certain types of depression
digoxin (a medicine used for heart problems)
diuretics (medicines to increase urine output)
ACE inhibitors or beta-blockers (classes of medicines used to treat high blood pressure and heart failure)
other anti-inflammatory medicines such as acetylsalicylic acid or ibuprofen
corticosteroids (medicines used to relieve inflammation in the body)
anticoagulants (medicines to prevent blood clotting)
medicines for diabetes (such as metformin), except insulin
methotrexate (a medicine used to treat certain types of cancer or arthritis)
ciclosporin, tacrolimus (medicines used mainly in transplant patients)
trimethoprim (a medicine used to prevent or treat urinary tract infections)
quinolone antibacterials (medicines used to treat infections)
voriconazole (a medicine used to treat fungal infections)
phenytoin (a medicine used to treat seizures)
rifampicin (an antibiotic used to treat bacterial infections). Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Elderly patients
Elderly patients, especially those who are frail or have low body weight, may be more sensitive.
...to the effects of ALMIRAL than other adult patients. Therefore, they should follow the doctor's instructions with particular care and take the lowest dose required for their condition. It is very important for elderly patients to report any adverse reactions to their doctor immediately.
Use in children and adolescents
ALMIRAL solution for injection must not be used in children and adolescents (under 18 years of age).

Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

You should not use ALMIRAL solution for injection if you are pregnant, unless it is absolutely necessary.
Do not take diclofenac if you are in the last 3 months of pregnancy, as it may harm your unborn baby or cause problems at delivery.

It may cause kidney and heart problems in your unborn baby. It may affect your and your baby's tendency to bleed and may cause labor to start later or last longer than expected.

You should not take diclofenac during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while trying to conceive, you should use the lowest dose for the shortest possible time. From the 20th week of pregnancy onwards, diclofenac may cause kidney problems in your unborn baby if taken for more than a few days, which may lead to low levels of the amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for longer than a few days, your doctor may recommend additional monitoring. You must inform your doctor if you are breastfeeding.

You should not breastfeed while taking ALMIRAL, as this may harm your baby.

Your doctor will discuss with you the potential risks of taking ALMIRAL during pregnancy or breastfeeding.

Women of childbearing potential
ALMIRAL may make it more difficult to become pregnant. You should not use ALMIRAL solution for injection if you are planning to become pregnant or are having difficulty conceiving.

ALMIRAL contains benzyl alcohol.
It must not be used in premature babies or newborns. It may cause toxic and anaphylactoid reactions in infants and children up to 3 years of age.

ALMIRAL contains propylene glycol.
It may cause symptoms similar to alcohol intoxication.

ALMIRAL contains sodium metabisulfite.
It may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use ALMIRAL
Always use this medicine exactly as your doctor has told you. If you are unsure about anything, ask your doctor or pharmacist.

How much ALMIRAL to use
Do not exceed the recommended dosage. It is very important to use the lowest dose of ALMIRAL solution for injection that relieves your pain and not to use more than necessary.

Your doctor will tell you exactly how much ALMIRAL solution for injection to use. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose. Adults
Typically, one ampoule is administered once every two days; in some cases, two ampoules may be administered. If treatment with ALMIRAL needs to be continued, tablets should be used.

How to use ALMIRAL
Intramuscular injections
The solution is drawn from the ampoule into a syringe and injected deep into the gluteal muscle.

Intravenous infusions
The solution is diluted with at least 100 ml of saline or glucose solution and infused slowly into a vein. Do not inject rapidly.

How long to use ALMIRAL
Follow your doctor's instructions exactly.

If you use ALMIRAL for more than a few weeks, you should visit your doctor for regular check-ups to ensure you are not experiencing any unnoticed adverse reactions.

If you have any further questions regarding the use of this medicine, ask your doctor or pharmacist.

If you use more ALMIRAL than you should
If you accidentally use more than the required dose, contact your doctor or pharmacist immediately or go to the nearest emergency medical center.

You may require medical attention.

If you miss a dose of ALMIRAL
If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your prescribed schedule. Do not take a double dose to make up for a missed dose. 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects with unknown frequency can be serious

Side effects with unknown frequency – the frequency cannot be estimated from the available data.

Stop using ALMIRAL and tell your doctor immediately if you notice:

Mild cramping and abdominal tenderness starting soon after the start of treatment with ALMIRAL and followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of the onset of abdominal pain.
Chest pain, which may be a sign of a potentially serious allergic reaction called sy
Kounis syndrome.
Injection site reactions, including injection site pain, redness, swelling, hardening, a hard lump, sores, and bruising. This can progress to blackening and death of the skin and underlying tissues around the injection site, healing with scarring—a condition also known as Nicolau syndrome.
A serious allergic skin reaction that may include large, widespread red and/or dark patches, skin swelling, blisters, and itching (generalized bullous fixed drug eruption).
Some rare or very rare side effects can be serious.
These uncommon side effects may affect between 1 and 10 in every 1,000 patients, especially when taking a high daily dose (150 mg) for a long period.

sudden, crushing chest pain (symptoms of myocardial infarction or heart attack)
shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (symptoms of heart failure)
These rare or very rare side effects may affect fewer than 1 to 10 in 10,000 patients. spontaneous bleeding or bruising (symptoms of thrombocytopenia)
high fever, frequent infections, persistent sore throat (symptoms of agranulocytosis)
difficulty breathing or swallowing, rash, itching, hives, dizziness (symptoms of hypersensitivity, anaphylactic or anaphylactoid reactions)
swelling primarily of the face and throat (symptoms of angioedema)
disturbing thoughts or moods (symptoms of mental disorders)
memory disturbances
seizures
restlessness
stiff neck, fever, nausea, vomiting, headache (symptoms of aseptic meningitis)
sudden and severe headache, nausea, dizziness, numbness, difficulty or inability to speak, weakness or paralysis of the limbs or face (symptoms of cerebrovascular accidents or heart attack)
reduced hearing (symptom of hearing impairment)
headache, dizziness (symptoms of high blood pressure, hypertension)
rash, purple-red spots, fever, itching (symptoms of vasculitis)
sudden difficulty breathing and a feeling of heaviness in the chest accompanied by wheezing or coughing (symptoms of asthma or pneumonia, if accompanied by high fever)
vomiting blood (symptoms of hematemesis) and/or dark or bloody stools (symptoms of gastrointestinal bleeding)
bloody diarrhea (symptoms of hemorrhagic diarrhea)
black stools (symptoms of melena)
stomach pain, nausea (symptoms of gastrointestinal ulcer, bleeding, or perforation)
diarrhea, abdominal pain, fever, nausea, vomiting (symptoms of colitis, including hemorrhagic colitis, ischemic colitis, and exacerbation of ulcerative colitis or Crohn's disease)
sudden severe pain in the upper abdomen (symptom of pancreatitis)
yellowing of the skin or eyes (symptoms of jaundice), nausea, loss of appetite,
dark urine (symptoms of hepatitis/liver failure)
flu-like symptoms, fatigue, muscle pain, elevated liver enzymes in blood tests (symptoms of liver damage, including fulminant hepatitis, liver necrosis, liver failure)
blisters (symptom of bullous dermatitis)
red or purple skin (possible sign of blood vessel inflammation),
skin rash with blisters on the lips, eyes, and mouth, skin inflammation with peeling and shedding (symptoms of erythema multiforme or—if accompanied by fever—Stevens-Johnson syndrome or toxic epidermal necrolysis)
skin rash with peeling and shedding (symptoms of exfoliative dermatitis)
increased skin sensitivity to sunlight (symptom of photosensitivity)
purple spots on skin (symptoms of purpura or Schönlein-Henoch purpura, if caused by an allergy)
swelling, feeling of weakness, impaired urination (symptoms of acute renal failure)
increased protein in the urine (symptom of proteinuria)
swelling of the face or abdominal area, high blood pressure (symptoms of nephrotic syndrome)
increase or decrease in urine output, drowsiness, confusion, nausea (symptoms of tubulo-interstitial nephritis)
severely reduced urine output (symptom of renal papillary necrosis)
generalized swelling (symptom of edema)
sudden chest pain and allergic reactions (signs of Kounis syndrome).
If you experience any of the listed conditions, inform your doctor immediately.

Some side effects are common
They occur in between 1 and 10 out of every 100 patients.

headache
dizziness
vertigo
nausea
vomiting
diarrhea
indigestion (symptoms of dyspepsia)
abdominal pain
flatulence
loss of appetite (symptoms of reduced appetite)
abnormal liver test results (e.g., elevated transaminase levels)
skin rash
injection site reactions
pain and hardening at the injection site
Some side effects are uncommon
They occur in between 1 and 10 out of every 1,000 patients. palpitations
chest pain
Some side effects are rare
They occur in between 1 and 10 out of every 10,000 patients
5. How to store ALMIRAL
Keep out of the reach of children.
Store in the original package.
Do not refrigerate or freeze.

Do not use this medicine after the expiry date stated on the carton and the label of each ampoule. The expiry date refers to the last day of that month.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information
What ALMIRAL contains
The active substance is diclofenac sodium. Each 3 ml glass ampoule contains 75 mg of diclofenac sodium.
The other ingredients are: benzyl alcohol, sodium formaldehyde sulfoxylate, propylene glycol, sodium metabisulfite, sodium hydroxide, water for injections.
What ALMIRAL looks like and contents of the pack
ALMIRAL solution for injection is a clear, colourless to pale yellow solution (3 ml) in Type I amber glass ampoules.

ALMIRAL solution for injection is supplied in amber glass ampoules containing 3 ml of diclofenac sodium (25 mg/ml), in packs of 5 or 10 ampoules. Not all types of packaging can be placed on the market.

 

 

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