Alermed

Alarmed, 10 mg, film-coated tablets Cetirizine dihydrochloride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
In case of any doubts, you should consult a doctor or pharmacist.
This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist.
Table of contents of the leaflet:

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

1. What is Alarmed and what is it used for

The active substance of Alarmed is cetirizine dihydrochloride.
Alarmed is an antiallergic medicine.
Alarmed, 10 mg, film-coated tablets are indicated for adults and children aged 6 years and older:

• for the relief of symptoms associated with seasonal and perennial allergic rhinitis,
  
• for the relief of symptoms of urticaria.

2. Important information before taking Alarmed

When not to take Alarmed:

• if the patient is hypersensitive to cetirizine dihydrochloride or any of the other ingredients of this medicine (listed in section 6), hydroxyzine or piperazine derivatives (active substances with a similar structure, which are part of other medicines);
• if the patient has severe renal impairment (renal failure with creatinine clearance less than 10 ml/min).

Warnings and precautions
Caution should be exercised when taking Alarmed in elderly patients, with renal or hepatic impairment.
Before taking Alarmed in children under 6 years of age, a doctor should be consulted, as there is insufficient data on the safety and efficacy of the medicine in this age group.
Alarmed should be avoided with alcohol, as alcohol may enhance the sedative effect of the medicine.
Alarmed may cause drowsiness in some patients. Caution should be exercised when driving or operating machinery.
Pregnancy and breastfeeding
In pregnancy and breastfeeding, a doctor should be consulted before taking the medicine.

3. How to take Alarmed

Take Alarmed always as directed by your doctor or pharmacist.
Adults and children over 6 years:

• Usually 1 tablet (10 mg) once daily.

Alarmed can be taken with or without food.
Do not exceed the recommended dose.
If symptoms persist after a few days of taking the medicine, a doctor should be consulted.

4. Possible side effects

Like all medicines, Alarmed can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people):

• Drowsiness, fatigue, dizziness, headache.
• Dry mouth.

Uncommon (may affect up to 1 in 100 people):

• Gastrointestinal disorders (e.g. nausea, vomiting, diarrhea, constipation).
• Rash, itching.
• Sleep disorders, agitation, nervousness.

Rare (may affect up to 1 in 1000 people):

• Urinary retention.
• Visual disturbances.
• Muscle pain.

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

• Allergic reactions (e.g. angioedema, anaphylactic shock).
• Hepatic disorders.

If any side effects occur, the medicine should be discontinued and a doctor or pharmacist consulted.

5. How to store Alarmed

Store in a cool, dry place, out of reach of children.

6. Contents of the pack and other information

10 mg, film-coated tablets
The pack contains 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 100, 120, 140, 168, 180, 200, 210, 252, 280, 300, 336, 360, 400, 500, 560, 600, 672, 700, 840, 900, 1000 film-coated tablets.

ARTICLE I. NAME

This organization shall be known as the National Association of Parliamentarians.

ARTICLE II. PURPOSE

The purpose of this Association shall be to promote parliamentary procedureand to assist members in becoming proficient in its practice.

ARTICLE III. MEMBERSHIP

Membership in the National Association of Parliamentarians shall be of three classes:

• Active
• Sustaining
• Honorary

SECTION 1. Active Members

Any person interested in parliamentary procedure may become an Active Member by payment of annual duesas established by the Board of Directors.

SECTION 2. Sustaining Members

Any person or organization may become a Sustaining Member by payment of annual duesas established by the Board of Directors. Sustaining Members shall not be entitled to vote.

SECTION 3. Honorary Members

Honorary Members shall be persons who have made outstanding contributions to the field of parliamentary procedureor to the Association. Honorary Members shall be nominated by the Membership Committee and approved by the Board of Directors. Honorary Members shall be exempt from payment of dues and shall be entitled to all privileges of Active Members except the right to hold office.

ARTICLE IV. OFFICERS

The officers of the National Association of Parliamentarians shall be:

1. President
2. First Vice President
3. Second Vice President
4. Secretary
5. Treasurer

SECTION 1. President

The President shall be the chief executive officerof the Association. The President shall preside at all meetings of the Association and of the Board of Directors. The President shall appoint all committees and shall have the power to fill vacancies in the Board of Directors until the next election.

SECTION 2. First Vice President

The First Vice President shall assist the President and shall act as President in the President’s absence. The First Vice President shall be responsible for the program of the Association.

SECTION 3. Second Vice President

The Second Vice President shall assist the President and the First Vice President and shall be responsible for the membership of the Association.

SECTION 4. Secretary

The Secretary shall keep the minutes of all meetingsof the Association and of the Board of Directors. The Secretary shall be responsible for the correspondence of the Association.

SECTION 5. Treasurer

The Treasurer shall be responsible for the financial affairs of the Association. The Treasurer shall keep accurate records of all receipts and disbursements and shall submit a financial reportto the Board of Directors at each meeting.

ARTICLE V. BOARD OF DIRECTORS

The Board of Directors shall consist of the officers of the Association and three Directors-at-Large. The Board of Directors shall have the general management of the affairs of the Association.

ARTICLE VI. ELECTIONS

Elections shall be held annuallyat the annual meeting of the Association. The election of officers shall be by secret ballot.

ARTICLE VII. AMENDMENTS

These Bylaws may be amended by a two-thirds voteof the members present at any regular meeting of the Association.

No significant clinical interactions have been observed between alcohol (at a concentration of 0.5 per mille (g/l)) in the blood, corresponding to the consumption of about one glass of wine, and cetirizine administered at the recommended doses. However, there are no data on the safety of concomitant use of higher doses of cetirizine and alcohol. Therefore, as with other antihistamine medicines, it is recommended to avoid taking Alarmed with alcohol.

If the patient has scheduled allergy tests, they should ask their doctor if they should stop taking Alarmed a few days before the test. Alarmed may affect the results of skin tests.

Children

This medicine should not be given to children under 6 years of age, as the tablet form does not allow for appropriate dose adjustment.

Alarmed and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.

Taking Alarmed with food and drink

Food does not affect the absorption of Alarmed.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor before taking this medicine.
Alarmed should be avoided in pregnant women. Accidental intake of the medicine by a pregnant woman should not have a harmful effect on the fetus. However, the medicine should only be used if necessary and after consulting a doctor.
Cetirizine passes into breast milk. Therefore, Alarmed should not be taken during breastfeeding, unless the doctor decides otherwise.

Clinical trials and machine operation

Clinical trials have not shown any impairment of alertness and concentration, as well as the ability to drive, after taking Alarmed. However, when performing tasks or operating machines, caution should be exercised, as Alarmed may cause drowsiness and reduce psychomotor performance in some individuals.
In sensitive patients, especially during the initial period of treatment, Alarmed may cause drowsiness. The patient should check how they react to the medicine before driving or operating machines.

How to take Alarmed

Take only as directed by your doctor or pharmacist.

• Adults and children over 6 years:usually 1 tablet once daily.

Do not take a higher dose than recommended.
If symptoms persist or worsen, a doctor should be consulted.

Overdose

In case of overdose of Alarmed, the patient should immediately contact a doctor or pharmacist for advice.
Symptoms of overdose may include drowsiness, dry mouth, dizziness, fatigue, headache, malaise, rapid heartbeat, tremor, urinary retention.
There is no specific antidote for cetirizine overdose. Treatment is symptomatic and supportive.

Use in children aged 6 to 12 years

The recommended dose is 5 mg twice daily (half a tablet twice daily). Other forms of this medicine may be more suitable for children. The patient should consult their doctor or pharmacist.
Patients with renal impairment
For patients with moderate renal impairment, a dose of 5 mg (half a tablet) once daily is recommended.
If the patient has severe renal impairment, they should consult their doctor, who will adjust the dose accordingly.
If the child has renal impairment, they should consult their doctor, who will adjust the dose according to the child's needs.
If the patient feels that the effect of Alarmed is too strong or too weak, they should consult their doctor.

Duration of treatment

The duration of treatment depends on the type, duration, and course of symptoms and is determined by the doctor.

Taking a higher dose of Alarmed than recommended

In case of taking a higher dose of Alarmed than recommended, the patient should immediately consult their doctor. The doctor will decide whether and what measures should be taken.
After overdose, the following side effects may occur with increased intensity: disorientation, diarrhea, dizziness, fatigue, headache, malaise, dilated pupils, itching, restlessness, sedation, stupor, rapid heartbeat, tremor, urinary retention.
Missing a dose of Alarmed
The patient should not take a double dose to make up for a missed dose.
Stopping Alarmed
In rare cases, itching (intense itching) and/or urticaria may recur after stopping Alarmed.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

• Common (may affect up to 1 in 10 people): drowsiness, fatigue, dizziness, dry mouth.
• Uncommon (may affect up to 1 in 100 people): visual disturbances, constipation, nausea, vomiting, allergic reactions (e.g. rash, urticaria, itching).
• Rare (may affect up to 1 in 1000 people): disorientation, headache, tremor, coordination disorders, speech disorders, sleep disorders, nightmares, restlessness, agitation, hallucinations, muscle cramps, urinary retention.
• Very rare (may affect up to 1 in 10,000 people): anaphylactic reactions (severe allergic reactions), angioedema (swelling of the face, tongue, throat), dyspnea.

Reporting side effects
If any side effects occur, the patient should report them to their doctor or pharmacist. This includes side effects not listed in the leaflet. They can be reported directly to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

Side effects that occur uncommonly (may occur less frequently than in 1 in 100 patients):

- abdominal pain,
- itching, rash,
- asthenia (extreme fatigue), malaise,
- restlessness,
- paresthesia (sensory disturbances),
- allergic reactions, sometimes severe (very rare),
- depression, hallucinations, aggressive behavior, disorientation, insomnia,
- convulsions,
- tachycardia (rapid heartbeat),
- abnormal liver function,
- syncope (fainting),
- edema (swelling),
- weight gain.

Side effects that occur very rarely (may occur less frequently than in 1 in 10,000 patients):

- blurred vision, accommodation disorders (vision disorders), eye rotation (uncontrolled, circular movements of the eyes),
- angioedema (severe allergic reaction causing swelling of the face or throat),
- drug rash,
- urinary disorders (nocturia, pain and/or difficulty urinating).

Side effects with unknown frequency (frequency cannot be estimated from available data):

- increased appetite,
- suicidal attempts (recurring suicidal thoughts or interest in suicide), nightmares,
- memory loss, memory disorders,
- dizziness (feeling of spinning or loss of balance),
- urinary retention (inability to completely empty the bladder),
- itching (intense itching) and/or urticaria after stopping Alarmed,
- sweating disorders.

Reporting side effects

If any side effects occur, the patient should report them to their doctor or pharmacist. This includes side effects not listed in the leaflet. They can be reported directly to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-305 Warsaw, phone: +48 22 492 13 01, fax: +48 22 492 13 02, website: https://www.urpl.gov.pl. Reporting side effects allows for the collection of information on the safety of the medicine.

Storage

Store at room temperature up to 25°C, in the original packaging to protect from light and moisture.

Other

This medicine should be taken as directed by the doctor.
The patient should inform their doctor about all medicines they are taking.
The patient should avoid consuming alcohol while taking this medicine.
In case of doubts, the patient should consult their doctor or pharmacist.

5. How to store Alarmed

Store at a temperature below 25°C.
The medicine should be stored in a place that is not visible and inaccessible to children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of in the sewage system or household waste containers. 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 pack and other information

What Alarmed contains
The active substance of Alarmed is cetirizine dihydrochloride. One film-coated tablet contains 10 mg of cetirizine dihydrochloride.
Other ingredients are: microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, lactose monohydrate, crospovidone, talc, lactitol monohydrate, macrogol 3350, hypromellose, titanium dioxide (E171).
What Alarmed looks like and what the pack contains
Alarmed is a white, round, film-coated tablet with a smooth surface and a score line that allows the tablet to be divided into two halves.
Alarmed is packaged in PVC/Aluminum or PVC/PVDC/Aluminum blisters, and then together with the patient leaflet in a cardboard box. The pack contains 20 or 30 film-coated tablets.
Alarmed is also packaged in a polyethylene container, and then together with the patient leaflet in a cardboard box. The pack contains 20 film-coated tablets.
Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer
LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14A
05-170 Zakroczym
Phone: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106
Date of last revision of the leaflet:

SECTION 5.0 - DISASTER RECOVERY

This section outlines the procedures for recovering from a disaster that affects the operation of the City’s critical systems. A disaster is defined as any event, natural or man-made, that disrupts normal business operations and requires the activation of the Disaster Recovery Plan.

5.1. Disaster Recovery Team

The Disaster Recovery Team (DRT) is responsible for coordinating and executing the Disaster Recovery Plan. The DRT consists of the following members:

• Team Leader:City Manager
• IT Coordinator:IT Director
• Facilities Coordinator:Public Works Director
• Communications Coordinator:City Clerk
• Department Representatives:Department Heads

The DRT will meet regularlyto review and update the Disaster Recovery Plan and to conduct disaster recovery exercises.

5.2. Disaster Declaration

A disaster will be declared by the City Manager, or in their absence, the Deputy City Manager. The declaration will be based on the severity of the event and its impact on the City’s operations. The declaration will trigger the activation of the Disaster Recovery Plan.

5.3. Recovery Procedures

The following procedures will be followed in the event of a disaster:

1. Assessment:The DRT will assess the damage and determine the extent of the disruption.
2. Activation:The Disaster Recovery Plan will be activated.
3. Notification:Key personnel will be notified.
4. Relocation:Critical operations will be relocated to the alternate site.
5. Restoration:Systems will be restored to normal operation.
6. Documentation:All recovery activities will be documented.

5.4. Alternate Site

The alternate sitefor critical operations is the County Emergency Operations Center. This site provides the necessary infrastructure, including power, communications, and workspace, to support the City’s critical functions.

5.5. Data Backup and Recovery

The City’s data is backed up dailyand stored offsite. In the event of a disaster, the data can be restored from the offsite backup location. The IT Director is responsible for ensuring that the data backup and recovery procedures are maintained and tested regularly.

5.6. Plan Maintenance

This Disaster Recovery Plan will be reviewed and updated annually, or as needed, to ensure its effectiveness. The DRT is responsible for maintaining the plan and conducting disaster recovery exercises.