Dirahist

Package leaflet: Information for the patient

Dirahist 1 mg + 2 mg hard capsules

Triamcinolone + Chlorpheniramine
Please read this leaflet carefully before taking 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 you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Dirahist is and what it is used for

Dirahist is a medicine with antihistaminic and corticosteroid activity, meaning it contains two active substances:

• triamcinolone, which belongs to a group of medicines called "glucocorticoids", which work by reducing and preventing inflammation
• chlorpheniramine, an antihistamine, a substance able to combat allergic reactions.

Dirahist is indicated:

• in all allergic diseases, especially those accompanied by excessive general or local release of histamine (a substance present in the body):
• urticaria (skin redness accompanied by itching)
• allergic rhinitis (hay fever)
• vasomotor rhinitis (non-allergic rhinitis)
• angioneurotic edema (swelling of hands, feet, ankles, face, lips, tongue and/or throat)
• allergic dermatitis and dermatoses (inflammatory skin reactions)
• pruritus (itching)
• bronchial asthma (a respiratory disease characterized by obstruction of the bronchi and lungs)
• allergic purpura (appearance of skin spots)
• conjunctivitis and other eye disorders (eye diseases characterized by intense itching and tearing)
• migraine (headache)
• headache of allergic origin
• food allergies
• allergic reactions following:
• blood transfusions
• administration of antibiotics or other medicines
• chemical substances (such as animal poisons)

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Dirahist

Do not take Dirahist

• if you are allergic to triamcinolone, chlorpheniramine, or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from tuberculosis (an infectious disease affecting the lungs)
• if you suffer from herpes simplex (a viral disease)
• if you suffer from systemic fungal infections (fungal infections affecting the whole body)

Your doctor will carefully evaluate the benefits versus the risks if you:

• have active peptic ulcer (a lesion affecting the mucosa of the stomach and intestine)
• have acute glomerulonephritis (an inflammatory kidney disease)
• have osteoporosis (a disease characterized by reduced bone mass, leading to increased bone fragility and risk of fractures)
• have thrombophlebitis (vein inflammation associated with thrombosis)
• have recently undergone stomach or intestinal surgery
• have diverticulitis (an intestinal disease caused by inflammation of one or more diverticula, localized dilations of one or more intestinal segments)
• have psychiatric disorders (disorders of thought and/or mood)
• have a local or systemic infection, including mycoses (fungal infections) and exanthematous diseases (diseases causing skin eruptions such as measles and chickenpox).

Warnings and precautions
Talk to your doctor or pharmacist before taking Dirahist.
In particular, inform your doctor if:

• you have hypothyroidism (reduced function of a gland located at the base of the neck called the thyroid) or hepatic cirrhosis (liver disease), as in these cases your response to glucocorticoids (medicines such as triamcinolone) may increase
• you are under stress, as your doctor may decide to adjust your dosage depending on the level of stress
• you suffer from acute or chronic infections, as your doctor must ensure that appropriate treatment with antibiotics and/or chemotherapeutic agents is implemented
• you are emotionally unstable or have psychotic tendencies (i.e. severe disturbances in an individual's psychological balance, impaired reality testing, and frequent presence of thought disorders), as these symptoms may be worsened by glucocorticoids
• an infection develops during treatment. In this case, your doctor will assess whether appropriate antibiotic therapy should be initiated
• during treatment you develop a disease of the glands near the kidneys (secondary adrenal insufficiency). In this case, your doctor will gradually reduce the dosage and, if necessary, may prescribe additional hormone therapy
• you need to be vaccinated against smallpox or receive other vaccinations involving activation of the immune system
• you experience blurred vision or other visual disturbances occur.

During prolonged therapy and with high doses, if an imbalance in water and electrolyte levels occurs, your doctor may advise adjusting your intake of sodium and potassium to restore balance. All glucocorticoids increase calcium excretion (see section 4 "Possible side effects").

For those engaged in sports
Using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

Other medicines and Dirahist
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicine.
In particular, inform your doctor if you are being treated with Dirahist and intend to take:

• anti-inflammatory medicines belonging to the salicylate group; in this case, if you also suffer from hypoprothrombinemia (a blood disorder characterized by a tendency to bleed), your doctor will monitor you closely
• the smallpox vaccine (an infectious disease); this vaccine must not be administered during treatment with glucocorticoids (present in Dirahist)
• other medicines acting on the body's defense system (immune system), especially at high doses
• oral contraceptives (birth control pills), ketoconazole (an antifungal medicine), and trioleandomycin (an antibiotic), which reduce glucocorticoid metabolism and thereby increase their side effects
• barbiturates (medicines acting on the central nervous system), phenytoin (an antiepileptic), carbamazepine (an antiepileptic), rifampicin (an antibiotic), aminoglutethimide (an anti-steroid agent), as these medicines may reduce the effectiveness of triamcinolone
• hypnotic medicines (which induce sleep), as they may enhance the central nervous system depressant effect of chlorpheniramine (one of the active ingredients in Dirahist).

Dirahist and alcohol
Alcohol consumption may increase the central nervous system depressant effect of chlorpheniramine.

Dirahist contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy, this product should be used only if clearly needed and under direct medical supervision.

Driving and using machines
Since this product may cause drowsiness, you should exercise caution when driving vehicles of any kind or operating machinery requiring full attention and vigilance.

3. How to take Dirahist

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is 1–2 capsules four times a day.
Your doctor will determine the optimal dose for you to control the symptoms of your allergic reaction;
if your doctor decides to reduce the dose, it should be reduced gradually.
If you take more Dirahist than you should
If you accidentally take a large amount of this medicine, contact your doctor or
go to the nearest hospital.
If you forget to take Dirahist
Do not take a double dose to make up for the missed dose.
Resume the prescribed treatment as soon as possible.
If you stop taking Dirahist
In long-term treatment, avoid abruptly stopping the therapy.
Before stopping treatment, consult your doctor.
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 everyone experiences them.
The following side effects have been observed and reported during treatment with Dirahist and cannot be classified by frequency:

Mental effects

• Euphoria
• Insomnia
• Drowsiness
• Fatigue
• Nervousness
• Tremors
• Mood or personality changes
• Severe depression
• Symptoms of actual psychoses (severe disturbance of the individual's mental balance, with impaired reality testing and frequent presence of thought disorders)

Blood-related effects

• Disturbances in the body's water and electrolyte balance (hydro-electrolytic balance); particularly decreased potassium levels in the blood (hypokalaemia), which in rare cases and in particularly predisposed patients may lead to increased blood pressure and congestive heart failure (heart disease accompanied by breathing difficulties)
• Alteration in the number of blood cells (blood dyscrasia)

Nervous system effects

• Dizziness
• Headache
• Increased pressure in the brain (intracranial pressure)
• Extrapyramidal disorders (such as changes in muscle tone and involuntary movements controlled by the network of neural pathways and centers that directly or indirectly influence movement, regulating instinctive reactions and adapting them to voluntary movement)

Metabolism and gland-related effects

• Altered gland function, which may present as:
• Menstrual irregularities
• Cushingoid appearance (a clinical condition characterized by excess hormones and the typical "moon face" appearance)
• Growth disturbances in children
• Interference with the function of hormone-producing glands (hypothalamic-pituitary-adrenal axis), particularly during periods of stress
• Reduced glucose tolerance and possible manifestation of latent diabetes mellitus (a disease caused by altered blood sugar levels)
• Increased need for medications to lower blood sugar levels (hypoglycaemic agents) in diabetic patients

Muscle and bone-related effects

• Muscle and bone disorders, such as osteoporosis, myopathies (i.e. muscle diseases), bone fragility

Skin-related effects

• Delayed wound healing
• Thinning and fragility of the skin
• Skin eruptions

Stomach and intestine-related effects

• Gastrointestinal complications that may lead to the development or activation of stomach lesions (peptic ulcer)

Eye-related effects

• Posterior subcapsular cataract (a disease caused by opacity located at the level of the posterior capsule of the eye's natural lens, the crystalline lens, manifesting with blurred vision)
• Increased intraocular pressure (increased amount of fluid produced inside the eye, leading to elevated pressure)
• Diplopia (double vision)
• Blurred vision, frequency not known (frequency cannot be determined based on available data)

Ear-related effects

• Sensation of ringing in the ears (tinnitus)

Blood vessel-related effects

• Transient reduction in blood pressure (transient hypotension)

Respiratory, thoracic and mediastinal effects

• Hiccups, frequency not known

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You may also report side effects directly via the national reporting system at https://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 Dirahist

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions. Store the product in its original packaging.
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.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dirahist contains

• The active substances are: Triamcinolone and Chlorpheniramine (1 capsule contains 1 mg of triamcinolone and 2 mg of chlorpheniramine maleate).
• The other components are: lactose, magnesium stearate, erythrosine (E 127), indigotine (E 132), titanium dioxide (E 171), gelatin.

Description of the appearance of Dirahist and package contents
Dirahist is presented as hard capsules, dark red in colour, packaged in blisters of 24 hard capsules.

Marketing Authorization Holder
Teofarma S.r.l.
Via F.lli Cervi, 8 – 27010 Valle Salimbene (PV)

Manufacturer
Teofarma S.r.l.
Viale Certosa, 8/A – 27100 Pavia